Drug delivery cassette

ABSTRACT

Disclosed is a drug-delivery cassette for use with a drug delivery device. The cassette includes a main board and a luer site base portion connected to the main board for positioning a luer on the main board. A drip chamber is included on the main board to collect any drug that exits the luer when the luer is attached to the luer site portion. A deflectable sensor beam is positioned to detect the presence or absence of a luer in the luer site base portion. The drug-delivery cassette further includes a drug vial spike attachable to and detachable from the cassette main board that is connected to the luer by way of a drug delivery tube.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of earlier filed provisionalapplications entitled “Medical Effector System Such As a SedationDelivery System (SDS) and Components Which Can Be Used Therein”, Ser.No. 60/629,137, filed on Nov. 18, 2004 and “Medical Effector System SuchAs a Sedation Delivery System (SDS) and Components Which Can Be UsedTherein”, Ser. No. 60/605,717, filed on Aug. 31, 2004, both of which areincorporated by reference herein.

RELATED APPLICATIONS

The present application relates to the following commonly assignedpatent applications “Medical Effector System” [END5298USNP], Ser. No.______; “Bite Block Assembly” [END5298USNP1], Ser. No. ______;“Apparatus For Monitoring A Patient During Drug Delivery”[END5298USNP2], Ser. No. ______; “Apparatus For Delivering Oxygen To APatient Undergoing A Medical Procedure” [END5298USNP4], Ser. No. ______;“Infusion Pump” [END5298USNP5], Ser. No. ______; “Capnometry System ForUse With A Medical Effector System” [END5298USNP6], Ser. No. ______;“Device For Connecting A Cannula To A Medical Effector System”[END5298USNP7], Ser. No. ______; “Apparatus To Deliver Oxygen To APatient” [END5298USNP8], Ser. No. ______; “Single Use Drug DeliveryComponents” [END5298USNP9], Ser. No. ______; “Drug Delivery Cassette AndA Medical Effector System” [END5298USNP10], Ser. No. ______; “Oral NasalCannula” [END5298USNP11], Ser. No. ______; all filed concurrentlyherewith; and Dose Rate Control, Ser. No. 10/886,255, filed on Jul. 7,2004; BIS Closed Loop Anesthetic Delivery, Ser. No. 10/886,322, filed onJul. 7, 2004; Patient Monitoring Systems and Method of Use, Ser. No.10/791,959, filed on Mar. 3, 2004; Air-Bubble-Monitoring MedicationAssembly, Medical System and Method, Ser. No. 10/726,845, filed on Dec.3, 2003; Cannula Assembly and Medical System Employing a Known CO₂ GasConcentration, Ser. No. 10/701,737, filed on Nov. 5, 2003; AutomatedAudio Calibration for Conscious Sedation, Ser. No. 10/674,244, filed onSep. 29, 2003; Response Testing for Conscious Sedation Using FingerMovement Response Assembly, Ser. No. 10/674,184, filed on Sep. 29, 2003;Personalized Audio Requests for Conscious Sedation, Ser. No. 10/674,185,filed on Sep. 29, 2003; Response Testing for Conscious SedationUtilizing a Non-Ear-Canal-Contacting Speaker, Ser. No. 10/674,183, filedon Sep. 29, 2003; Response Testing for Conscious Sedation Involving HandGrip Dynamics, Ser. No. 10/674,160, filed on Sep. 29, 2003; ResponseTesting for Conscious Sedation Utilizing a Hand Motion Response, Ser.No. 10/673,660, filed on Sep. 29, 2003; Response Testing for ConsciousSedation Utilizing a Cannula for Support/Response, Ser. No. 10/670,453,filed on Sep. 25, 2003; Time Variant Vibration Stimulus Response for aConscious Sedation System, Ser. No. 10/670,489, filed on Sep. 25, 2003;Response Testing for Conscious Sedation using Cableless Communication,Ser. No. 10/671,183, filed on Sep. 25, 2003; System and Method forMonitoring Gas Supply and Delivering Gas to a Patient, Ser. No.10/660286, filed on Sep. 11, 2003; Drug Delivery System and Method, Ser.No. 10/660201, filed Sep. 11, 2003; and Battery Backup Method andSystem, Ser. No. 10/660285, filed Sep. 11, 2003, all of which areincorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention is related generally to medical systems andcomponents, which can be used in medical systems, and more particularlyto a medical effector system, such as a sedation delivery system, andcomponents, which can be used therein.

BACKGROUND OF THE INVENTION

A conscious sedation system is known and described in U.S. Pat. No.6,745,764 entitled “Apparatus and method for providing a consciouspatient relief from pain and anxiety associated with medical or surgicalprocedures”. In that system, a procedure room unit included acontroller, which generated a request for a predetermined response froma patient. The request was in the form of an auditory command, which wasreceived by a patient through an earphone in the ear of the patient orwas in the form of a vibration signal, which was received by the patientthrough a vibrator in a handpiece, which was attached to the hand of thepatient. The predetermined response to the request was the pushing of abutton on the handpiece by the patient, which closed a switch sending asignal to the controller. The controller analyzed medical informationfrom the patient. Such medical information included, for example, bloodpressure from a blood pressure cuff attached to the procedure room unitand placed on the arm of the patient and respiratory carbon dioxidelevels obtained from a cannula (which also delivered oxygen to thepatient) attached to the procedure room unit and placed on the face ofthe patient. The controller also analyzed the time delay between therequest and the response. Based on the medical information and the timedelay between the request and the response, the controller determinedthe level of sedation of the patient and decreased the flow of a gaseousor IV (intravenous) conscious sedation drug to the patient if thecontroller determined the patient was in a deeper level of conscioussedation than desired.

It is known to deliver IV sedation drugs to a patient from adrug-delivery cassette assembly using a peristaltic pump wherein thecassette assembly and pump are attached to the procedure room unit.

Still, scientists and engineers continue to seek improved medicaleffector systems, such as sedation delivery systems, and components,which can be used therein.

SUMMARY OF THE INVENTION

Various embodiments of the invention include a cannula assembly, a biteblock, a drug-delivery cassette assembly (which is used in adrug-delivery infusion pump assembly which is a type of drug-deliveryflow control assembly which is an example of a drug-delivery medicaleffector), an energy-delivery medical effector, a procedure room unit,an interface between a procedure room unit and a bedside monitoringunit, a bedside monitoring unit, and components thereof, which can beused separately and in various combinations including in a medicaleffector system such as a sedation delivery system.

This invention is directed toward use in a minimal sedation, moderate“conscious” sedation or deep sedation procedure, but not to ananesthesia or “general anesthesia” application as defined by theAmerican Society of Anesthesiologists (ASA) in the document “Continuumof Depth of Sedation: Definition of General Anesthesia and Levels ofSedation/Analgesia, approved by the ASA house of delegates on Oct. 13,1999, and amended on Oct. 27, 2004. The ASA defines general anesthesiaas a drug-induced loss of consciousness during which patients are notarousable, even by painful stimulation. Further, patients often requireassistance in maintaining a patient airway, and positive pressureventilation may be required because of depressed spontaneous ventilationor drug-induced depression of neuromuscular function, cardiovascularfunction may be impaired.

In short, this invention provides a means for a procedural physicianoutside the practice of anesthesiology to provide sedation and/or painrelief to patients. The automation provided by the invention compensatesfor lack of clear standards of practice for non-anesthetists to guidethe relief of pain and anxiety for conscious patients. Moreover, theinvention will subsidize the limited training available to proceduralphysicians in the diagnosis and treatment of complications that mayarise or result from the provision of sedation and analgesia toconscious patients.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of an embodiment of a cannula assembly ofthe invention, including the cannula, BMU-connector and tubes and of anembodiment of an earpiece and an audio tube;

FIGS. 2 and 3 are cross-sectional views of tubing, taken along lines 2-2and 3-3 of FIG. 1, showing separate lumens that conduct gases to/fromthe oral/nasal cannula;

FIG. 4 is a perspective view of the oral/nasal cannula of FIG. 1 withoutany connecting tubes;

FIG. 5 is a cross-sectional view taken along lines 5-5 in FIG. 4 of aportion of the cannula cap and cannula body showing the bending of arespiratory-gas-sampling nasal prong of the cannula body because of thelocation of the tube-receiving hole of a respiratory-gas-delivery nasalprong of the cannula cap when the cannula cap is attached to the cannulabody;

FIG. 6 is a block diagram identifying elements of an embodiment of anoral/nasal cannula assembly, including the oral/nasal cannula of FIG. 1,and identifying elements of an embodiment of a medical gasanalysis/delivery system of an embodiment of an SDS (sedation deliverysystem), which is an example of a medical effector system, including anembodiment of a PRU (procedure room unit) and an embodiment of a BMU(bedside monitoring unit);

FIG. 7 is a top planar view of the oral/nasal cannula of FIG. 4 with thecannula cap removed;

FIGS. 8 and 9 are cross-sectional views of the oral/nasal cannula ofFIG. 7, taken along lines 8-8 and 9-9 of FIG. 7, indicating paths foroxygen and CO₂ gases;

FIG. 10 is a distal end view of the oral/nasal cannula BMU connector ofFIG. 1 without any connecting tubes;

FIG. 11 is a cross-sectional view of the oral/nasal cannula BMUconnector of FIG. 10, taken along lines 11-11 in FIG. 10, showing therecess for the nasal moisture chamber;

FIG. 12 is an enlarged view of a portion of the oral/nasal cannula BMUconnector of FIG. 11 showing details of CO₂ gas lines;

FIG. 13 is an exploded view of the oral/nasal cannula connector of FIG.10 showing the outlet cover, gasket and back plate;

FIG. 14 is a schematic, side-elevational, cross-sectional view of thenasal moisture trap chamber of FIG. 13;

FIG. 15 is proximal connecting-end view of the back plate of theoral/nasal cannula connector of FIG. 13 identifying individual ports;

FIG. 16 is a proximal end view of the outlet cover of the oral/nasalcannula of FIG. 13;

FIGS. 17 and 18 are cross-sectional views of the outlet cover of FIG.16, taken along lines 17-17 and 18-18 of FIG. 16, indicating paths forgases and moisture chamber details;

FIG. 19 is a front elevational view of a first embodiment of a biteblock and a portion of a first alternate embodiment of a cannula;

FIG. 20 is a cross-sectional view of the bite block of FIG. 19 takenalong the lines 20-20 of FIG. 19 with the addition of a medicalinstrument inserted in the through passageway of the bite block;

FIG. 21 is a view, as in FIG. 20 but of a second embodiment of a biteblock;

FIG. 22 is a view, as in FIG. 20 but of a third embodiment of a biteblock;

FIG. 23 is a schematic diagram of a further embodiment of a medicaleffector system having a cannula, wherein the medical effector systemalerts a user of a possible problem with the cannula;

FIG. 24 is a top perspective view of an embodiment of a drug-deliverycassette assembly of the invention;

FIG. 25 is a bottom perspective view of the drug-delivery cassetteassembly of FIG. 24;

FIG. 26 is an exploded view of the drug-delivery cassette assembly ofFIG. 24 showing individual components;

FIG. 27 is a perspective view of the luer-site base portion (also calleda T-site base area when the luer is “T”-shaped) of the drug-deliverycassette assembly of FIG. 26;

FIG. 28 is a perspective view of the spike bed area of the drug-deliverycassette assembly of FIG. 26;

FIG. 29 is a top planar view of the drug-delivery-cassette main board ofthe drug-delivery cassette assembly of FIG. 26;

FIGS. 30 and 31 are cross-sectional views of the drug-delivery-cassettemain board of FIG. 29, taken along lines 30-30 and 31-31 in FIG. 29,showing the vial sensor beam and the T-site sensor beam;

FIG. 32 is a perspective view of the spike of the drug-delivery cassetteassembly of FIG. 26;

FIG. 33 is an end view of the spike of FIG. 32;

FIG. 34 is a cross-sectional view (which has been rotated ninety degreescounterclockwise) of the spike of FIG. 33 taken along lines 34-34 ofFIG. 33;

FIGS. 35 and 36 are a right-side and left-side perspective views of thespike cap of the drug-delivery cassette assembly of FIG. 26 showingdetails of the cap handle and latching system;

FIG. 37 is a side elevational view of the spike cap of the drug-deliverycassette assembly of FIG. 26;

FIG. 38 is an end elevational view of the spike cap of the drug-deliverycassette assembly of FIG. 26;

FIG. 39 is a top planar view of the spike cap of the drug-deliverycassette assembly of FIG. 26;

FIG. 40 is a cross-sectional view of the spike cap of FIG. 39, takenalong lines 40-40 in FIG. 39, showing the spike hollow;

FIG. 41 is a perspective view of the sedation delivery system (SDS) ofFIG. 6, which is an example of a medical effector system, including theprocedure room unit (PRU), the bedside monitoring unit (BMU), and theumbilical cable;

FIG. 42 is a front perspective view of the SDS cart and the PRU of FIG.41 including the universal power supply (UPS) of the PRU;

FIG. 43 is a top perspective view of the PRU of FIG. 41 with aninstalled drug-delivery cassette assembly and with the pump-housing doorclosed;

FIG. 44 is a top perspective view of a portion of the PRU of FIG. 43with the pump-housing door open and with an uninstalled drug-deliverycassette assembly;

FIG. 45 is a top perspective view of a portion of the PRU of FIG. 43with an installed drug-delivery cassette assembly and with thepump-housing door open;

FIG. 46 is a top perspective view of a portion of the PRU of FIG. 43with an installed drug-delivery cassette assembly, with the pump-housingdoor closed, and with an about-to-be-installed drug vial;

FIG. 47 is a top perspective view of a portion of the PRU of FIG. 43with an installed drug-delivery cassette assembly, with the pump-housingdoor closed, and with an installed drug vial;

FIG. 48 is an exploded view of the PRU of FIG. 43;

FIG. 49 is a rear perspective view of a portion of the PRU of FIG. 43;

FIG. 50 is a front perspective view of the oxygen-delivery manifold seeninstalled in the rear of the PRU in FIG. 49;

FIG. 51 is a rear perspective view of the oxygen-delivery manifold ofFIG. 50;

FIG. 52 is a cross-sectional view of the oxygen-delivery manifold ofFIG. 51 taken along arrows 52-52 in FIG. 51;

FIG. 53 is an enlarged view of a portion of the oxygen-delivery manifoldof FIG. 52;

FIG. 54 is a top perspective view of the PRU host controller of the PRUof FIG. 43;

FIG. 55 is an exploded view of the drug-delivery infusion pump assemblyof the PRU of FIG. 43;

FIG. 56 is a rear perspective view of the UPS of FIG. 42;

FIG. 57 is an exploded view of the UPS of FIG. 42;

FIG. 58 is a schematic view of an alternate embodiment of a medicaleffector system of the invention including an energy-delivery medicaleffector;

FIG. 59 is a schematic diagram of an embodiment of a medical effectorsubsystem having a drug-delivery infusion pump subassembly, wherein themedical effector subsystem alerts a user of an occluded drug-deliverytube;

FIG. 60 is a front perspective view of the BMU of FIG. 41 withconnecting lines attached;

FIG. 61 is a bottom perspective view of the BMU of FIG. 41 withconnecting lines detached;

FIG. 62 is an exploded view of the BMU of FIG. 41;

FIG. 63 is a block diagram identifying elements of an embodiment of asedation delivery system (SDS);

FIG. 64 is a block diagram identifying elements of an embodiment of aprocedure room unit (PRU) for use in an SDS of FIG. 63;

FIG. 65 is a block diagram identifying elements of a system board foruse with a PRU of FIG. 64;

FIG. 66 is a block diagram of a drug delivery module for use with a PRUof FIG. 64;

FIG. 67 is a block diagram of an oxygen delivery module for use with aPRU of FIG. 64;

FIG. 68 is a block diagram of a power board module for use with a PRU ofFIG. 64;

FIG. 69 is a block diagram of a printer module for use with a PRU ofFIG. 64;

FIG. 70 is a block diagram of an uninterruptible power supply (UPS) foruse with a PRU of FIG. 64;

FIG. 71 is a block diagram of a UPS module for use with a UPS of FIG.70;

FIG. 72 is a block diagram of a bedside monitoring unit (BMU) for usewith an SDS of FIG. 63;

FIG. 73 is a block diagram of a BMU expansion board for use with a BMUof FIG. 72;

FIG. 74 is a block diagram of a display assembly for use with an SDS ofFIG. 63;

FIG. 75 is a block diagram of single-patient-use (SPU) items for usewith an SDS of FIG. 63;

FIG. 76 is a block diagram of multiple-patient-use (MPU) items for usewith an SDS of FIG. 63;

FIG. 77 is diagrammatical process flow of the BMU and PRU of an SDS ofFIG. 63 during one example of a surgical procedure;

FIG. 78 is an overview data-flow diagram depicting the pre-medicalprocedure aspect of an SDS of FIG. 63;

FIG. 79 is an overview data-flow diagram depicting the medical procedureaspect of an SDS of FIG. 63; and

FIG. 80 is an overview data-flow diagram depicting the post-medicalprocedure aspect of an SDS of FIG. 63.

FIG. 81 is a front perspective of the peripheral monitor used inconjunction with the PRU.

DETAILED DESCRIPTION OF THE INVENTION

Before explaining the present invention in detail, it should be notedthat the invention is not limited in its application or use to thedetails of construction and arrangement of parts and steps illustratedin the accompanying drawings and description. The illustrativeembodiments of the invention may be implemented or incorporated in otherembodiments, variations and modifications, and may be practiced orcarried out in various ways. Furthermore, unless otherwise indicated,the terms and expressions employed herein have been chosen for thepurpose of describing the illustrative embodiments of the presentinvention for the convenience of the reader and are not for the purposeof limiting the invention.

A medical effector is a device adapted to deliver at least one medicalsubstance and/or at least one type of medical energy locally and/orgenerally to a patient during a medical procedure. A medical procedureincludes, without limitation, a medical diagnostic procedure, a medicaltherapy procedure, and/or a surgical procedure. A medical substance isat least one gas, liquid, and/or solid having alone and/or together amedical effect on a patient, and an example is a pharmaceutical drug.Medical energy is energy having a medical effect on a patient. Anexample, without limitation, of a medical effect is a sedative effect.The terminology “sedative effect” includes conscious sedation andunconscious (anesthetic) sedation depending on the type and/or amount ofthe medical substance and/or medical energy being used. For purposes ofdescribing the embodiments of the invention, an analgesic effect isconsidered to be a sedative effect, and an amnestic effect is consideredto be a sedative effect. An example, without limitation, of a medicalsubstance having a sedative effect is the sedation drug Propofol. Anexample, without limitation, of a medical effector for deliveringPropofol to a patient is a drug-delivery flow control assembly such as adrug-delivery infusion pump assembly. An example, without limitation, ofa type of medical energy having a sedative effect is a time-varyingmagnetic field as described in U.S. Pat. No. 6,712,753. An example,without limitation, of a medical effector for delivering a time-varyingmagnetic field to a patient is at least one magnetic flux generator asdescribed in U.S. Pat. No. 6,712,753. Thus, a sedation delivery systememploying a sedation-drug-delivery flow control assembly and a sedationdelivery system employing at least one magnetic flux generator areexamples of sedation medical effector systems. Other examples of medicaleffector systems, medical effectors, medical substances, drugs, types ofmedical energy, medical effects, and medical procedures are left to theartisan. It is noted that the hereinafter-used terms “attachable”,“attached”, “connectable”, and “connected” include, respectively,directly or indirectly attachable, directly or indirectly attached,directly or indirectly connectable, and directly or indirectlyconnected. It is further noted that describing an apparatus as having aparticular component means that the apparatus has at least one suchparticular component. Likewise, describing a component as having aparticular feature means that the component has at least one suchparticular feature.

Various aspects and embodiments of the invention are hereinafterdescribed, for ease of understanding, with reference to a sedationdelivery system 100 and a sedation drug-delivery flow control assembly220′, but it is understood that such aspects and embodiments have equalapplication with reference to other examples of medical effector systems100′ than a sedation delivery system 100 and/or to other examples ofmedical effectors 220″ than a drug-delivery flow control assembly 220′.Such other examples include, without limitation, a medical effectorsystem including a non-sedation drug-delivery flow control assembly anda medical effector system including at least one magnetic fluxgenerator.

It is further understood that any one or more of the following-describedaspects, embodiments, expressions of embodiments, examples, etc. can becombined with any one or more of the other following-described aspects,embodiments, expressions of embodiments, examples, etc.

Cannula Assembly

A first aspect of the invention is directed to, or a component of, orcan be used by, a cannula assembly 145, an embodiment of which is shownin FIGS. 1-18. A first expression of the embodiment of FIGS. 1-18 is fora cannula assembly 145 including an oral-nasal cannula 351 and aslidable tube 371′. The oral-nasal cannula 351 is disposable on the faceof a patient 10 and includes a respiratory-gas-sampling nasal prong 364or 365 and a respiratory-gas-sampling oral prong 369′. The slidable tube371′ is slidably connected to one of the respiratory-gas-sampling nasaland oral prongs 364, 365 or 369′ to accommodate different distancesbetween the nose and mouth of different patients 10. In one example, theslidable tube 371′ is slidably connected to the respiratory-gas-samplingoral prong 369′, wherein the slidable tube 371′ has a substantiallyright-angle bend and a distal end 14, and wherein, when the oral-nasalcannula 351 is disposed on the face of the patient 10, the distal end 14of the slidable tube 371′ extends distally toward or into the mouth ofthe patient 10. Other examples are left to the artisan.

A second expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 including a cannula 351′ (such as, but not limited to, anoral-nasal cannula 351) and a user-detachable oral prong extension 370′or 370″. The cannula 351′ is disposable on the face of a patient 10 andincludes a respiratory-gas-sampling or respiratory-gas-delivery oralprong 369′/371′ or 369″/371″ having an opening. The user-detachable oralprong extension 370′ or 370″ comes removably attached to the oral prong369′/371′ or 369″/371″ and is user-connectable to the opening of theoral prong 369′/371′ or 369″/371″. In one example of the secondexpression of the embodiment of FIGS. 1-18, the oral prong 369′ or 369″lacks the slidable prong 371′ or 371″, and in another example it doesnot. In one implementation of the second expression, the oral prongextension 370′ or 370″ is connected to the opening of the oral prongwhen the user is employing a bite block (not shown) with the patientsuch as during esophageal procedures requiring an endoscope. In oneillustration, the user-detachable oral prong extension 370′ or 370″ ismanually detached by the user without the use of any tool. In oneconstruction, the oral prong extension 370′ or 370″ comes removablyattached to the oral prong 369′/371′ or 369″/371″ by amanually-breakable tether 12. Alternate constructions include removableattachment by use of score lines or perforations. Other examples,implementations, and constructions are left to the artisan.

A third expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 comprising a cannula 351′ which is disposable on the faceof a patient 10 and which includes a respiratory-gas-sampling oral prong369′/371′ having a distal end 14 and a respiratory-gas-delivery oralprong 369″/371″ having a distal end 16 wherein, when the cannula 351′ isdisposed on the face of the patient 10, the distal end 14 of therespiratory-gas-sampling oral prong 369′/371′ extends distally furthertoward or into the mouth of the patient 10 than the distal end 16 of therespiratory-gas-delivery oral prong 369″/371″. In one example of thethird expression of the embodiment of FIGS. 1-18, therespiratory-gas-sampling oral prong 369′/371′ is a carbon-dioxiderespiratory-gas-sampling oral prong, and the respiratory-gas-deliveryoral prong 369″/371″ is used to deliver air with an enriched oxygencontent (sometimes just referred to as “oxygen”) to the patient 10. Inthis example, such staggering of the distal ends 14 and 16 of the twoprongs 369′/371′ and 369″/371″ reduces oxygen dilution of thecarbon-dioxide sample, as can be appreciated by those skilled in theart. Other examples are left to the artisan.

A fourth expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 comprising a cannula 351′ which is disposable on the faceof a patient 10 and which includes left and right cannula support wings367′ and 367″ each having a wing tip portion with an adhesive pad 366removably adhesively attachable to a side of the face of the patient 10.In one example, no other attachment is used to secure the cannula 351′to the face of the patient 10. In this example, the adhesive pad 366provides for a more convenient cannula attachment for the patient than aconventional headband, etc. Other examples are left to the artisan.

A fifth expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 comprising a cannula 351′ which is disposable on the faceof a patient 10, which includes a cannula body 18 having arespiratory-gas-sampling nasal prong 364 or 365, and which includes acannula cap 368 having a respiratory-gas-delivery nasal prong 422 with atube-receiving hole 26. The cannula cap 368 is attached to the cannulabody 18 with the respiratory-gas-sampling nasal prong 364 or 365 passingthrough and extending beyond the tube-receiving hole 26. Thetube-receiving hole 26 is disposed to bend the respiratory-gas-samplingnasal prong 364 or 365 toward the nose of the patient 10 when thecannula 351′ is disposed on the face of the patient 10. This arrangementallows for better respiratory gas sample acquisition as can beappreciated by those skilled in the art. In one example of the fifthexpression of the embodiment of FIGS. 1-18, the nasal prong 364 or 365is substantially straight before the cannula cap 368 is attached to thecannula body 18.

A sixth expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 comprising a cannula 351′ which is disposable on the faceof a patient 10 and which includes a respiratory-gas-sampling nasalprong 364 or 365 having a distal end 20 and a respiratory-gas-deliverynasal prong 422′ or 422″ having a distal end 22, wherein, when thecannula 351′ is disposed on the face of the patient 10, the distal end20 of the respiratory-gas-sampling nasal prong 364 or 365 extendsdistally further toward or into one of the nostrils of the patient 10than the distal end 22 of the respiratory-gas-delivery nasal prong 422′or 422″. Such staggering of the distal ends 20 and 22 of the two prongs364 or 365 and 422′ or 422″ reduces respiratory delivered gas dilutionof the respiratory gas sample, as can be appreciated by those skilled inthe art. In one example of the sixth expression of the embodiment ofFIGS. 1-18, the respiratory-gas-sampling nasal prong 364 or 365 iscircumferentially surrounded by the respiratory-gas-delivery nasal prong422′ or 422″. Other examples are left to the artisan.

A seventh expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 including an oral-nasal cannula 351 and a connector 363.The oral-nasal cannula 351 is disposable on the face of a patient 10 andincludes a left-nostril respiratory-gas-sampling tube 354, aright-nostril respiratory-gas-sampling tube 352, and an oralrespiratory-gas-sampling tube 355. The connector 363 includes a cover394 and a back plate 423 attached to the cover 394. The cover 394includes an interior nasal moisture trap chamber 412 and an interiororal moisture trap chamber 411 isolated from the interior nasal moisturetrap chamber 412. The back plate 423 includes a nasal capnometry port402 and an oral capnometry port 400. The left and right nostrilrespiratory-gas-sampling tubes 354 and 352 are connected to the cover394 and are in fluid communication with the interior nasal moisture trapchamber 412. The oral respiratory-gas-sampling tube 355 is connected tothe cover 394 and is in fluid communication with the interior oralmoisture trap chamber 411. The nasal capnometry port 402 is in fluidcommunication with the interior nasal moisture trap chamber 412. Theoral capnometry port 400 is in fluid communication with the interiororal moisture trap chamber 411.

In one example of the seventh expression of the embodiment of FIGS.1-18, the connector 363 also includes a hydrophobic filter 395′ disposedbetween the interior nasal moisture trap chamber 412 and the nasalcapnometry port 402 and a hydrophobic filter 395″ disposed between theinterior oral moisture trap chamber 411 and the oral capnometry port400. In another example, not shown, a desiccant is disposed in the nasaland oral moisture trap chambers 412 and 411. Other examples are left tothe artisan.

In one variation of the seventh expression of the embodiment of FIGS.1-18, the connector 363 also includes an inter-flow-path-sealing gasket396 disposed between the interior nasal and oral moisture trap chambers412 and 411 and the nasal capnometry and oral capnometry ports 402 and400. The gasket 396 includes annular towers 24 which extend into thenasal capnometry and oral capnometry ports 402 and 400 and provide, atleast in part, the fluid communication between the interior nasalmoisture trap chamber 412 and the nasal capnometry port 402 and betweenthe oral moisture trap chamber 411 and the oral capnometry port 400.

An eighth expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 including a cannula 351′ and a connector 363. The cannula351′ is disposable on the face of a patient 10 and includes arespiratory-gas-sampling tube 354, 352 or 355. The connector 363includes a cover 394, a back plate 423, and a gasket 396. The back plate423 is attached to the cover 394. The cover 394 includes an interiormoisture trap chamber 412 or 411. The back plate 423 includes acapnometry port 402 or 400. The respiratory-gas-sampling tube 354, 352or 355 is connected to the cover 394 and is in fluid communication withthe interior moisture trap chamber 412 or 411, and the capnometry port402 or 400 is in fluid communication with the interior moisture trapchamber 412 or 411. The gasket 396 is disposed between the interiormoisture trap chamber 412 or 411 and the capnometry port 402 or 400. Thegasket 396 includes an annular tower 24 which extends into thecapnometry port 402 or 400 and provides, at least in part, the fluidcommunication between the interior moisture trap chamber 412 or 411 andthe capnometry port 402 or 400.

A ninth expression of the embodiment of FIGS. 1-18 is for acannula-assembly connector 363. The cannula-assembly connector 363includes at least one cannula-assembly connector member together havinga nasal capnometry port 402, an oral capnometry port 400, a nasalpressure port 401, and a respiratory-gas-delivery port 399. Each of theports 402, 400, 401 and 399 is fluidly-connectable to a bedsidemonitoring unit (BMU) 300 (an embodiment of which is seen in FIGS. 6 and60-62) of a sedation delivery system (SDS) 100 (or other type of medicaleffector system 100′). The terminology “fluidly-connectable” includesdirectly fluidly-connectable and indirectly fluidly-connectable.

In one example of the ninth expression of the embodiment of FIGS. 1-18,the at-least-one cannula-assembly connector member consists of a plate(e.g., back plate 423). In the same or a different example, each of theports 402, 400, 401 and 399 has a center and the distance between thecenters of any two ports 402, 400, 401 and 399 is shortest for the nasalcapnometry and nasal pressure ports 402 and 401. In one extension of theninth expression, the at-least-one cannula-assembly connector membertogether have an audio port 398. In one construction, the connector 363includes a back plate 423, wherein one or more or all of the ports402,400, 401 and 399 (and, when present, 398) are ports of the backplate 423. In one variation, the back plate 423 includes adapter pins397 for aligning and/or assisting in connecting the ports 402, 400, 401and 399 (and, when present, 398) to the BMU 300. In one modification,the back plate 423 is configured as shown in FIGS. 13 and 15. In anotherconstruction, not shown, the connector 363 lacks a plate or a backplate. In one arrangement, the BMU 300 has ports, which enter the ports402, 400, 401 and 399 (and, when present, 398) of the connector 363 toprovide the fluid connection. In another arrangement, the ports 402,400, 401 and 399 (and, when present, 398) of the connector 363 enterports on the BMU 300 to provide the fluid connection. Other arrangements(including connector ports which are flush with the back plate, notshown) providing the fluid connection of the connector ports and the BMUare left to the artisan.

In one implementation of the ninth expression of the embodiment of FIGS.1-18, the bedside monitoring unit (BMU) 300 is fluidly-connectable to aprocedure room unit (PRU) 200 (an embodiment of which is shown in FIGS.6 and 41-57) of the sedation delivery system (SDS) 100 (or other type ofmedical effector system 100′). The procedure room unit 200 includes anoral capnometer 202 and a nasal capnometer 140 (see FIG. 54). When theoral and nasal capnometry ports 400 and 402 of the connector 363 arefluidly connected to the bedside monitoring unit 300 and the bedsidemonitoring unit 300 is fluidly connected to the procedure room unit 200,the oral capnometer 202 is in fluid communication with the oralcapnometry port 400 and the nasal capnometer 140 is in fluidcommunication with the nasal capnometry port 402. The terminology“fluidly connected” includes directly fluidly connected and indirectlyfluidly connected.

A tenth expression of the embodiment of FIGS. 1-18 is for a cannulawater-trap subassembly 28 including a cannula water-trap housing 30 anda hydrophobic filter 395. The cannula water-trap housing 30 includes amoisture trap chamber 411 or 412 having a moisture-collection cavity 32and a sampled-respiratory-gas pass-through cavity 34. Thesampled-respiratory-gas pass-through cavity 34 is disposed higher than,and in fluid communication with, the moisture-collection cavity 32. Thesampled-respiratory-gas pass-through cavity 34 has a smaller volume thanthe moisture-collection cavity 32. The sampled-respiratory-gaspass-through cavity 34 has a sampled-respiratory-gas entrance and asampled-respiratory-gas exit. The hydrophobic filter 395 is disposed tocover the exit of the sampled-respiratory-gas pass-through cavity 34.All sampled respiratory gas 36 entering the sampled-respiratory-gaspass-through cavity 34 must pass through the hydrophobic filter 395 toexit the sampled-respiratory-gas pass-through cavity 34. Moisture in thesampled respiratory gas 36 collects in the moisture-collection cavity32.

An eleventh expression of the embodiment of FIGS. 1-18 is for a cannulaassembly 145 including a cannula 351′, a connector 363, and an audioearpiece 362. The cannula 351′ is disposable on the face of a patient 10and includes a respiratory-gas-sampling tube 354, 352 or 355. Therespiratory-gas-sampling tube 354, 352 or 355 is fluidly-connected tothe connector 363, and the connector 363 is connectable to a bedsidemonitoring unit 300 of a sedation delivery system 100 (or other type ofmedical effector system 100′). The audio earpiece 362 is disposableproximate an ear of the patient 10 and is operatively-connected to theconnector 363 to give sound to the patient 10 at least at the directionof the bedside monitoring unit 300 when the connector 363 is connectedto the bedside monitoring unit 300 and the audio earpiece 362 isdisposed proximate the ear of the patient 10. The term “proximate”includes, without limitation, “in” and “on”.

In one example of the eleventh expression of the embodiment of FIGS.1-18, the audio earpiece 362 is disposable in the ear of the patient 10,and the cannula assembly 145 includes an audio (i.e., sound) tube 356which is operatively-connected to the audio earpiece 362 and to theconnector 363 and which acoustically transmits sound from a speaker inthe bedside monitoring unit (BMU) 300 to the audio earpiece 362 when theconnector 363 is connected to the BMU 300. In one employment, the BMU300 uses the audio earpiece 362 to provide the patient 10, while in thepre-procedure room, with training commands to squeeze an automatedresponse monitor (e.g., a handpiece) to establish a patient responsetime while conscious. In one variation, a training computer program inthe BMU 300 controls the speaker during such training. Thereafter, thepatient 10, while in the procedure room undergoing sedation, is providedoperational commands to squeeze the automated response monitor at therequest of a procedure room unit (PRU) 200 of the sedation deliverysystem 100 (or other type of medical effector system 100′). The PRU 200uses at least the patient response time to determine a level ofconsciousness of the patient 10 undergoing sedation (or other type ofmedical procedure). In one variation, a computer program in the PRU 200controls the speaker during patient sedation. In another employment,soothing sounds, such as music, are given to the patient in thepre-procedure room by the audio earpiece 362. In a different example,the audio earpiece 362 is a speaker on a headset and the audio tube 356is replaced by electric wiring. Other examples are left to the artisan.

In one application of any of the above-described expressions of FIGS.1-18, including examples, etc. thereof, the cannula assembly 145 isdirectly connectable to the Bedside Monitoring Unit (BMU) 300. Forexample, in one application of the seventh expression of the embodimentof FIGS. 1-18, the connector 363 is directly connectable to the BedsideMonitoring Unit (BMU) 300, wherein inlet ports of the BMU 300 enter theannular towers 24 of the gasket 396 and compress the annular towers 24against the corresponding nasal capnometry and oral capnometry ports 402and 400 to provide a leak-free seal. In a different application of anyof the above-described expressions of FIGS. 1-18, including examples,etc. thereof, the cannula assembly 145 is directly connectable to a unit(not shown) that stays in the procedure room. For example, in adifferent application of the seventh expression of the embodiment ofFIGS. 1-18, the connector 363 is directly connectable to a unit (notshown) that stays in the procedure room. In one variation, the unit (notshown) includes delivery of a sedation drug(s) to the patient 10, and inanother variation, the unit (not shown) does not include delivery of asedation drug(s) to the patient. Other applications are left to theartisan.

Any one or more of the above-described expressions of the embodiment ofFIGS. 1-18, including examples, etc. thereof can be combined with anyother one or more of the above-described expressions of the embodimentof FIGS. 1-18, including examples, etc. thereof, as can be appreciatedby those skilled in the art.

FIGS. 19 and 20 show a first embodiment of a bite block 74, which, inone example, is used with the cannula assembly 145 of FIGS. 1-18. A biteblock, in one example, is used on a patient during anupper-gastrointestinal endoscopic medical procedure. The bite block hasa bite-block body, which is inserted into the mouth of the patient. Thebite-block body has a through passageway for insertion of an endoscopetherethrough. The patient bites down on the bite-block body instead ofon the endoscope.

A first expression of the embodiment of FIGS. 19 and 20 is for a biteblock 74 including a bite-block body 76 adapted for insertion into themouth of a patient. The bite-block body 76 includes a through passageway78 and includes an air sampling passageway 80 spaced apart from thethrough passageway 78. The through passageway 78 is adapted forreceiving therethrough a medical instrument 82 (only an unhatchedportion of which is shown in FIG. 20). The air sampling passageway 80has an inlet 84 disposed to receive exhaled air from the patient whenthe bite-block body 76 is inserted into the mouth of the patient. Theair sampling passageway 80 has an outlet 86 adapted for coupling to arespiratory gas sampling port 88 of a cannula 90 (only the body/capportion of an embodiment of an oral/nasal cannula withoutrespiratory-gas-delivery prongs is shown). In one variation, the outlet86 of the air sampling passageway 80 is adapted for indirectly couplingto the respiratory gas sampling port 88 of the cannula 90 through aconnector tube 92.

A second expression of the embodiment of FIGS. 19 and 20 is for acannula assembly 94 including a cannula 90, a bite block 74, and aconnector tube 92. The cannula 90 is disposable on the face of a patientand includes a respiratory gas sampling port 88. The bite block 74 has abite-block body 76 adapted for insertion into the mouth of a patient.The bite-block body 76 includes a through passageway 78 and includes anair sampling passageway 80 spaced apart from the through passageway 78.The through passageway 78 is adapted for receiving therethrough amedical instrument 82. The air sampling passageway 80 has an inlet 84disposed to receive exhaled air from the patient when the bite-blockbody 76 is inserted into the mouth of the patient and has an outlet 86.The connector tube 92 having a first end attached or attachable to therespiratory gas sampling port 88 of the cannula 90 and has a second endattached or attachable to the bite-block body 76 at the outlet 86 of theair sampling passageway 80 of the bite-block body 76.

FIG. 21 shows a second embodiment of a bite block. An expression of theembodiment of FIG. 21 is for a bite block assembly 96 including abite-block body 98 and an air sampling tube 102. The bite-block body 98is adapted for insertion into the mouth of a patient and includes athrough passageway 104 adapted for receiving therethrough a medicalinstrument 106 (only a portion of which is shown). The air sampling tube102 is attached to the bite-block body 98, has an inlet 108 disposed toreceive exhaled air from the patient when the bite-block body 98 isinserted into the mouth of the patient and has an outlet 112 attached orattachable to a respiratory gas sampling port of a cannula.

In one variation of the embodiment of FIG. 21, the air sampling tube 102is at least partially disposed within the through passageway 104. In oneconstruction, the air sampling tube 102 is adhesively attached to thebite-block body 98. In one employment, the outlet 112 of the airsampling tube 102 is adapted for indirect attachment to the respiratorygas sampling port of the cannula through a connector tube 118.

FIG. 22 shows a third embodiment of a bite block. An expression of theembodiment of FIG. 22 is for a bite block assembly 122 including abite-block body 124 and an air sampling tube 126. The bite-block body124 is adapted for insertion into the mouth of a patient. The bite-blockbody 124 includes a through passageway 128 adapted for receivingtherethrough a medical instrument 132 (only a portion of which is shown)and includes an air sampling passageway 134. The air sampling tube 126is at least partially disposed within the air sampling passageway 134,has an inlet 136 disposed to receive exhaled air from the patient whenthe bite-block body 124 is inserted into the mouth of the patient, andhas an outlet 138 attached or attachable to a respiratory gas samplingport of a cannula. In one variation, the outlet 138 of the air samplingtube 126 is adapted for indirect attachment to the respiratory gassampling port of the cannula through a connector tube 148.

Examples of the embodiments of FIGS. 19 and 20, 21, and 22 have theadvantage of maintaining the air sampling passageway/tube in properair-sampling position despite movement of the instrument in the throughpassageway during a medical procedure. This results in more accuratecarbon dioxide gas concentration measurements of the exhaled air of thepatient than is achieved with conventional bite block and cannulaarrangements which employ a cannula having an air sampling tube whichdoes not stay in position relative to the bite block.

FIG. 23 shows a further embodiment of a medical effector system 154,wherein the medical effector system 154 alerts a user of a possibleproblem with a cannula 156 of the medical effector system 154. Anexpression of the embodiment of FIG. 23 is for a medical effector system154 including a pressure sensor 158, a cannula 156, and a memory 166.The pressure sensor 158 includes an input 168 and has an output signal170. The cannula 156 is disposable on the face of a patient and includesa respiratory-gas-sampling tube 172 operatively connectable to the input168 of the pressure sensor 158. The memory 166 contains a cannulaprogram which when running on a processor 174 is operatively connectedto the output signal 170 of the pressure sensor 158. The cannula programalerts a user of a possible problem with the cannula 156 based at leastin part (and in one example based entirely) on the output signal 170 ofthe pressure sensor 158. It is noted that, in one example, the input 168of the pressure sensor 158 is for receiving a pneumatic signal in theform of respiratory gas from the patient.

In one deployment of the embodiment of FIG. 23, when the cannula 156 isdisposed on the face of the patient and when therespiratory-gas-sampling tube 172 is operatively connected to the input168 of the pressure sensor 158, the output signal 170 of the pressuresensor 158 corresponds to the pressure generated by the patient'sbreathing which is a time varying signal corresponding to the breathrate of the patient. If no cannula 156 is disposed on the face of thepatient and/or if the respiratory-gas-sampling tube 172 of the cannula156 is not operatively connected to the input 168 of the pressure sensor158, then the output signal 170 (which typically is an electricalsignal) of the pressure sensor 158 would substantially equal that ofatmospheric pressure.

In one construction of the embodiment of FIG. 23, therespiratory-gas-sampling tube 172 is adapted to sample respiratory gasfrom at least one of the mouth, left nostril and right nostril of thepatient. In one variation, not shown, the respiratory-gas-sampling tubeis adapted to sample respiratory gas from the mouth and both nostrils ofthe patient. In another variation, not shown, therespiratory-gas-sampling tube is adapted to sample respiratory gas fromjust both nostrils of the patient. In an additional variation, therespiratory-gas-sampling tube 172 is adapted to sample respiratory gasfrom just one of the left nostril, right nostril, and mouth of thepatient.

In one employment of the embodiment of FIG. 23, the possible cannulaproblem includes the cannula 156 not being disposed (or not beingdisposed properly) on the face of the patient when the cannula programis running on the processor 174. In the same or a different employment,the possible cannula problem includes the cannula 156 not beingoperatively connected to the input 168 of the pressure sensor 158 whenthe cannula program is running on the processor 174.

In one application of the embodiment of FIG. 23, the pressure sensor 158is a component of a bedside monitoring unit (e.g., the bedsidemonitoring unit 300 of FIG. 6 wherein pressure sensor 158 would replacenasal pressure transducer 47). In the same or a different application,the memory 166 and the processor 174 are components of a host controllerof a procedure room unit (such as host controller 204 of the procedureroom unit 200 of FIG. 6). In one variation, the medical effector system154 also includes an umbilical cable (such as the umbilical cable 160 ofFIG. 6). In this variation, the cannula program automatically startsrunning after the bedside monitoring unit and the procedure room unitare operatively connected together with the umbilical cable when atleast one of the bedside monitoring unit and the procedure room unit hasbeen turned on. In one employment, the possible problem with the cannulaincludes the umbilical cable not being connected (or not being properlyconnected) to the bedside monitoring unit and the procedure room unit.In one modification, the procedure room unit includes a capnometer 230and 234 operatively connectable to the cannula 156, and the cannulaprogram starts the capnometer 230 and 234 if the cannula program doesnot alert the user of the possible problem with the cannula 156. Inanother application, the pressure sensor 158, the memory 166, theprocessor 174, and the capnometer 230 and 234 are components of a singleunit.

In one arrangement of the embodiment of FIG. 23, therespiratory-gas-sampling tube 172 is an oral respiratory-gas samplingtube 236, the cannula 156 also includes a left-nostrilrespiratory-gas-sampling tube 238 operatively connectable to the input168 of the pressure sensor 158, and the cannula 156 additionallyincludes a right-nostril respiratory-gas-sampling tube 240 operativelyconnectable to the input 168 of the pressure sensor 158. In onevariation, at least one valve 242, 244 and 246 is controllable by thecannula program to selectively operatively connect to the pressuresensor 158, one at a time, the oral, left-nostril and right-nostrilrespiratory-gas-sampling tubes 236, 238 and 240. Other configurationsusing a different number of valves, different valve design, and/ordifferent valve connections than that shown in FIG. 23 are left to theartisan. In one modification, the medical effector system 154 alsoincludes at least one capnometer 230 and 234, wherein the at-least-onevalve 242, 244 and 246 is controllable by the cannula program tooperatively connect the oral, left-nostril and right-nostrilrespiratory-gas-sampling tubes 236, 238 and 240 to the at-least-onecapnometer 230 and 234. In one application, the at least one capnometer230 and 234 includes a nasal capnometer 230 which receivesrespiratory-gas-sampling input from both nostrils of the patient and anoral capnometer 234 which receives respiratory-gas-sampling input fromthe mouth of the patient. In one implementation, the nasal capnometer230 and the oral capnometer 234 are components of a procedure room unit(such as the previously-discussed procedure room unit 200). It is notedthat the connections between the processor 174 and the capnometers 230and 234 and between the processor 174 and the at-least-one valve 242,244 and 246 have been omitted from FIG. 23 for clarity. In otherarrangements, not shown, two or three pressure sensors are employed.

In other configurations, not shown, of a medical effector system whichalerts a user of a possible problem with a cannula, each valve 242, 244and 246 (which in one example also has an off position blocking any flowfrom exiting the valve) of FIG. 23 is replaced with a splitter whichdivides the associated respiratory-gas-sampling tube into one branchconnected to the associated capnometer and another branch connected tothe pressure sensor. In one variation, one, two or three pressuresensors and/or one, two or three capnometers are employed. It is notedthat, in one deployment, the strongest pressure signal from a breathingsite identifies the best breathing site for use in capnometermeasurements of carbon dioxide in the exhaled breath of the patient.

In one example, benefits of the medical effector system 154 includeautomatically alerting the user of a possible problem with the cannula156 without employing less reliable mechanical switches and includeproviding baseline pressure measurements for a patient's oral breathingand nasal breathing. Such baseline pressure measurements, in oneapplication, are used to later determine if a patient's preferredbreathing orifice has changed whereupon the flow rate of oxygen to thepatient undergoing a medical procedure is raised or lowered.

The following paragraphs present a detailed description of oneparticular enablement of the embodiment of FIGS. 1-18. It is noted thatany feature(s) of this particular enablement can be added to any of thepreviously-described expressions (including examples, etc. thereof) ofthe embodiment of FIGS. 1-18. In this particular enablement, the cannulaassembly 145 is an oxygen (the term “oxygen” includes air with anenriched oxygen content) delivery cannula assembly, more specifically acannula assembly 145 (shown in FIG. 1) that supplies oxygen to a patient10 and collects oral and nasal exhaled breath samples for analysis. Theoral/nasal cannula 351 allows for measurement of end-tidal CO₂ gas (theterm “CO₂ gas” means gas containing CO₂) from both oral and nasalcavities, as well as measurement of CO₂ gas pressure from combined nasalcavities.

Oral/nasal cannula 351 provides a stream of oxygen directed into theoral and nasal cavities, unlike prior art cannulas, which provide oxygenas a cloud to the exterior of the oral or nasal cavities. Cannulaassembly 145 includes a nasal pressure sensor line that provides asignal to an oxygen controller to decrease oxygen flow rates duringexhalation thus preventing dilution of the end-tidal gas sample,increasing measurement accuracy. Cannula 145 allows for independent oraland nasal capnometry measurement, different from prior art capnometrycannulas, which combine the sampling to come up with an averagemeasurement. The invention also includes a connector 363 as an integralpart of the cannula system to facilitate easy attachment and removalfrom Bedside Monitoring Unit (BMU) 300. Cannula 145 also provides forthe delivery of audible commands to a patient 10 requesting a responsefor an Automated Responsiveness Monitor (ARM).

In one construction, oral nasal cannula 351 is made of a soft pliablematerial that is easily deformable and will fit comfortably on apatient's 10 face. This ensures patient 10 comfort and minimizeirritation.

Cannula assembly 145 (shown in FIG. 1) is part of an integratedmonitoring and sedation delivery system (SDS) intended to provide a safemeans to administer sedation drug in surgical procedures. The systemuses a drug delivery algorithm and an intravenous infusion peristalticpump to deliver drug(s) with variable rate infusion that achieves andmaintains a desired sedation effect. All drug delivery is performed by aProcedure Room Unit (PRU) 200, which together with a Bedside MonitoringUnit (BMU) 300 enables the care team to make necessary drug dosingchanges possible from any location.

As used herein, the term “proximal” refers to a location on theoral/nasal cannula assembly closest to the device using the cannulaassembly and thus furthest from the patient 10 on which the cannulaassembly is used. Conversely, the term “distal” refers to a locationfarthest from the device using the cannula assembly and closest to thepatient 10.

As illustrated on FIGS. 1-3, oral/nasal cannula 351 is designed to fitcomfortably upon the upper lip of a patient 10 between the nose andmouth. Oral/nasal cannula 351 functions as a mask-free deliveryapparatus for supplying oxygen gas to a patient 10 while also providingfor the monitoring of patient 10 breathing. Oral/nasal cannula 351 isconnected to a set of tubing for gas sample collection, audio and oxygendelivery, and includes cinch 361 to help secure to the patient 10, anearpiece 362 to allow audio messages to be sent to the patient 10, andBMU connector 363 for secure connection to the bedside monitoring unit(BMU) 300.

Referring to FIGS. 1 and 6, the cannula assembly 145 includes distaloral-nasal cannula 351 earpiece 362 and proximal connector 363.Exhalation samples from the patient 10 are collected by oral-nasalcannula 351 and flow through independent channels and lumens toconnector 363. Connector 363 is removably attached to bedside monitoringunit (BMU) 300. Gases (oxygen and CO₂) are then routed via the umbilicalto/from procedure room unit (PRU) 200. The capnometry system includestwo capnometers in PRU 200. A particle and hydrophobic filter arelocated inside cannula connector 363. Oral chamber 411 and nasal chamber412 are designed to trap condensation from the patient's 10 exhaledbreath to avoid moisture damage to the capnometers. A nasal pressuretransducer 47 is located in the bedside monitoring unit (BMU) 300. Thepressure transducer 47 provides patient 10 breathing information toprocedure room unit (PRU) 200 through the umbilical cable.

As shown in FIG. 4, oral-nasal piece 351 is made of soft and flexiblematerial, such as polyurethane, silicon or some other elastomer, and isgenerally constructed by either injection-molding or liquid injectionmolding techniques. Cannula cap 368 is generally a hollow cube and isthe platform for supporting other features. Oral-nasal piece 351 profileis designed to easily adapt to patient 10 anatomy. Oral-nasal cannula351 includes adhesive pads 366 located on the patient 10 side of cannulawings 367 and are intended to adhere to and secure comfortablyoral-nasal piece 351 in place on the patient 10's face. Cannula cap 368includes nasal prong 422 and oral prong 369. Cannula body 18 includesnasal prongs 364 and 365 and oral prongs 370 and 371.

FIGS. 4 and 6-9 illustrate that cannula cap 368 includes two independentgas circuits, one for collecting oral and nasal exhaled CO₂ forcapnometry and pressure analysis, and a second for supplying oxygen intothe patient's 10 nose and mouth. FIG. 8 shows a cross-section view ofthe oral/nasal cannula 351 CO₂ sampling circuit. The CO₂ samplingcircuit comprises a left and right nostril circuit and oral samplecircuit, which are internally molded and interconnected inside cannulacap 368. CO₂ left circuit is comprised of left prong channel 375 andleft channel 377, interconnected at right angles, and functioning tocollect CO₂ samples from the patient's 10 left nostril. Left sample tube354 (FIG. 1) is inserted into and fixedly attached to left channel 377,which divides the CO₂ sampling volume into two lumens (shown on FIGS.2-3 and 6): left pressure lumen 359 and left sample lumen 360. Inaddition, CO₂ right circuit is comprised of right prong channel 374 andright channel 376, interconnected at right angles, and functioning tocollect CO₂ samples from the patient 10's right nostril. Right sampletube 352 (FIG. 1) is inserted into and fixedly attached to right channel376, which divides the CO₂ sampling volume into two lumens (shown onFIGS. 2-3 and 6): right pressure lumen 357 and right sample lumen 358.The arrangement is essentially the same for an oral circuit whichcomprises an oral prong channel 379 within oral prongs 369, 371 and 370;and an oral channel 378 inside cannula cap 368. Oral prong channel 379and oral channel 378 are interconnected and collect CO₂ samples from thepatient 10's mouth.

As illustrated in FIGS. 7-9, a second gas circuit delivers oxygen in theproximity of the patient's 10 nose and mouth. FIG. 9 shows across-section view of oral/nasal cannula 351. Oxygen channel 387 is influid communication with chamber 384 within cannula cap 368. Oxygenchamber 384 has three openings: a first opening connecting to oxygenprong channel 381, which delivers oxygen in the vicinity of the mouth; asecond opening which communicates with right channel 385 that deliversoxygen into the right nostril; and a third opening which delivers oxygento the left nostril through channel 386.

As shown on FIG. 4, nasal oxygen prongs 422 are mounted over prongs 364and 365. Prongs 422 have a tapered shape and fit co-axial around nasalprongs 364 and 365. Prongs 422 include a number of holes to permitoxygen passage from within cannula cap 368 to the vicinity of thepatient's 10 nostrils.

The oral system is comprised of oral prongs 369 which are an integralpart of oral-nasal cannula 351, sliding prongs 371 which are slidablymounted over prongs 369, and EGD (esophageo-gastro-duodenoscopy) prongextension 370. The oral prong system consists of two independentchannels: oxygen prong channel 381 for oxygen supply; and oral prongchannel 379 for CO₂ sample collection. Sliding prongs 371 are slidablymounted over prongs 369 forming an “L” shape and allow for flexibilityin adapting to different patients 10. Prongs 369 are extendable andretractable to be easily positioned in front of the mouth. A third piececomprising the oral prong system are detachable/attachable prongextension EGD (esophageo-gastro-duodenoscopy) prongs 370, which aredesigned to mount slidably on sliding prongs 371 to reach inside thepatient's 10 mouth. EGD prong extension 370 is manufactured tethered toprongs 371 but is easily detached by the user. EGD extension 370improves the delivery and collection of gases into the mouth, but can beeasily removed and discarded if not used.

As shown on FIG. 1, the tubing set is comprised of two extruded tubes352 and 354 for transporting CO₂ nasal samples, each tube set containingtwo small lumens, tube 355 for transporting the CO₂ oral sample, audiotube 356, and oxygen tube 353 to transport oxygen into chamber 384(shown in FIGS. 7-9). The tubes are commercially available andpreferably constructed of pliable plastic material such as extrudedpolyvinyl chloride. Each extruded tube 352 and 354 transports CO₂samples from right and left nostrils, respectively. Sample tube 352 isconnected to cannula cap 368 adjacent oxygen tube 353 on the right side.In a similar arrangement sample tube 354 is connected to cannula cap 368adjacent oral sample tube 355 on the left side.

Now referring to FIGS. 2 and 3, right pressure lumen 357 and rightsample lumen 358 are located within tube 352 and transport CO₂ gassamples from the right nostril for pneumatic and capnometry analysis. Inthe same form, left pressure lumen 359 and left sample lumen 360 arelocated within tube 354 to transport CO₂ gas samples from the leftnostril. In one arrangement, tube 352 is adhered to oxygen tube 353, andin the same manner, tube 354 is adhered to oral sample tube 355. Theconnection between tubes is designed such that the tubes can be easilyseparated as needed. A separate audio tube 356 is attached to earpiece362 and is used to transport sound to the patient 10's ear.

As illustrated on FIG. 13, oral/nasal cannula connector 363 is comprisedof four components which when assembled together form internal chambersand channels. The components are outlet cover 394, hydrophobic filter395, gasket 396, and back plate 423. The components are held together byinternal latches 403 which are snapped and locked onto internal notches404.

Referring to FIGS. 10-13 and 15-18, outlet cover 394 and back plate 423are made of molded rigid thermoplastic, while gasket 396 is made of anelastic, flexible material. Included in outlet cover 394 are moisturechambers 411 and 412 used for trapping moisture from oral and nasal CO₂sampling gases. Outlet cover 394 includes gripper snaps 388 tofacilitate the user securely attaching the connector assembly to the BMUinterface connector (shown on FIG. 1). Left and right nasal CO₂ gasesare combined in recess 415 after passing through capnometry outletchannels 417 (shown on FIGS. 16-18). The nasal capnometry analysis isperformed on the combined gas sample in PRU 200 (see FIG. 6). Pressureanalysis is also made on a combined gas sample after CO₂ gases passthrough pressure lines 424 (FIG. 12).

Oral capnometry analysis is performed on a CO₂ gas sample, which istaken after gas has passed through oral outlet channel 416 and into oralrecess 410 and moisture chamber 411 (see FIG. 6). Recesses 410 and 415hold hydrophobic filter 395 which traps moisture and allows it to draininto moisture chambers 411 and 412, preventing moisture damage to othersensitive parts of the capnometry system.

Referring to FIGS. 1 and 10-13, the distal face of outlet cover 394provides connectors for all cannula tubing. The distal face of cover 394includes oxygen tube opening 390, which is the connection point for tube353, audio tube opening 389 which is the connection point for tube 356,right tube opening 392 which receives sample tube 352, left tube opening393 connecting to sample tube 354, and oral tube opening 391 whichreceives oral sample tube 355. All connection points are designed tocreate a leak tight seal with the mating tubing. Both right and leftnasal CO₂ pressure lines 418 (see FIG. 16) connect to pressure lumenports 421 located in recess 420.

As best illustrated on FIGS. 13 and 15, gasket 396 is sandwiched betweenoutlet cover 394 and back plate 423. Its function is to create internalchannels and to isolate individual flow paths. It also secureshydrophobic filter 395. Hydrophobic filter 395 is also held by filternotch 419 and bumps 413 located on outlet cover 394 proximal face.Hydrophobic filter 395 is commercially available and has the propertiesof being particle-blocking and hydrophobic. Back plate 423 includes anumber of ports that interface with the connector on BMU 300 (FIG. 1)including audio port 398, oxygen port 399, oral port 400, and pressureport 401. Adaptor pins 397 function to guide the connection betweencannula connector 363 and the connector on BMU 300.

It is noted that in the detailed description of the one particularenablement of the embodiment of FIGS. 1-18, the cannula 351′, theconnector 363, and the earpiece 362 are single-patient-use (SPU) items.

Drug-Delivery Cassette Assembly

A second aspect of the invention is directed to, or a component of, orcan be used by, a drug-delivery cassette assembly 251, an embodiment ofwhich is shown in FIGS. 24-40 and which, in one enablement is used in anembodiment of a procedure room unit (PRU) 200 shown in FIGS. 41-57. Afirst expression of the embodiment of FIGS. 24-40 is for a drug-deliverycassette assembly 251 including a luer 269, tubing 277 and 259 and adrug-delivery-cassette main board 253. The tubing 277 and 259 has adrug-receiving end, which is fluidly-connectable to a drug vial 250containing a drug, and has a drug-delivery end, which isfluidly-connected to the luer 269. The terminology “fluidly-connectable”includes directly fluidly-connectable and indirectlyfluidly-connectable, and the terminology “fluidly-connected” includesdirectly fluidly-connected and indirectly fluidly-connected. Thecassette main board 253 has a luer-site base portion 271. The luer 269is attachable to and detachable from the luer-site base portion 271. Theluer-site base portion 271 has a deflectable luer-site sensor beam 275which is disposed to be deflected by the luer 269 when the luer 269 isattached to the luer-site base portion 271 and to be undeflected whenthe luer 259 is detached from the luer-site base portion 271. Theluer-site base portion 271 is also referred to, in one construction, asa T-site base 271, and the luer-site sensor beam 275 is also referredto, in that one construction, as a T-site sensor beam 275. Otherconstructions are left to the artisan.

In one example of the first expression of the embodiment of FIGS. 24-40,the cassette main board 253 is attachable to and detachable from aprocedure room unit (PRU) 200 (shown in FIGS. 41-57) having aluer-in-place optical sensor 226 (see FIG. 44) disposed to sense onlyone of the deflected luer-site sensor beam 275 and the undeflectedluer-site sensor beam 275. In one variation, the procedure room unit 200controls flow of the drug in the tubing 277 and 259 to air purge thetubing 277 and 259 and to deliver the drug through the tubing to apatient based at least in part on the luer-in-place optical sensor 226sensing or not sensing the luer-site sensor beam 275. Other examples areleft to the artisan.

A broad description of a combination of the second aspect of theinvention (a drug-delivery cassette assembly embodiment of which isshown in FIGS. 24-40) and a later-discussed third aspect of theinvention (a procedure room unit embodiment of which is shown in FIGS.41-57) is for a drug-delivery assembly (e.g., drug-delivery cassetteassembly 251 and procedure room unit 200). In one expression of thecombination, the drug-delivery assembly (e.g., 251 and 200) includestubing (e.g., 277 and 259), a storage site (e.g., luer-site base portion271), a pump (e.g., 220 as seen in FIG. 41), and a sensor (e.g.,luer-in-place optical sensor 226, as seen in FIG. 44). The tubing (e.g.,277 and 259) has a drug-receiving end that is fluidly-connectable to adrug vial (e.g., 250) containing a drug and has a drug-delivery endportion (e.g., luer 269). The storage site (e.g., 271) is adapted forreleasably storing the drug-delivery end portion (e.g., 269) of thetubing (e.g., 277 and 259) when the drug-delivery end portion of thetubing is not in drug-delivering communication with a patient. The pump(e.g., 220) controls flow of the drug in the tubing (e.g., 277 and 259),when the tubing (e.g., 277 and 259) is operatively connected to the pump(e.g., 220), to air purge the tubing (e.g., 277 and 259) and to deliverthe drug through the tubing (e.g., 277 and 259) to the patient. Thesensor (e.g., 226) has an output and is disposed to sense the presenceand/or absence of the drug-delivery end portion (e.g., 269) of thetubing (e.g., 277 and 259) in the storage site (e.g., 271).

It is noted that, in one example of the broadly-described combination,the drug-delivery end portion of the tubing has a length ofsubstantially one to four inches and includes any end fitting (e.g.,luer 269) attached to the drug-delivery end portion of the tubing (e.g.,277 and 259) itself. In one application, the sensor directly senses thepresence and/or absence of the drug-delivery end portion (e.g., 269) ofthe tubing (e.g., 277 and 259) in the storage site (e.g., 271). Inanother application, the sensor (e.g., 226) indirectly senses thepresence and/or absence of the drug-delivery end portion (e.g., 269) ofthe tubing (e.g., 277 and 259) by sensing the presence and/or absence ofanother component (e.g., the luer-site sensor beam 275) which changesposition between the presence and absence of the drug-delivery endportion (e.g., 269) of the tubing (e.g., 277 and 259) in the storagesite (e.g., 271). It is understood that the recited components are notlimited to the particular component examples found in parenthesesfollowing the components. Thus, other examples of a sensor can be usedsuch as, without limitation, another optical sensor, an ultrasonicsensor, a proximity sensor, or an electromagnetic sensor. Likewise,other examples of a storage site, etc. can be used, and thedrug-delivery system is not limited to requiring a drug-deliverycassette assembly and/or a procedure room unit, as can be appreciated bythe artisan.

In one implementation of the drug-delivery assembly (e.g., 251 and 200),the pump (e.g., 220) air purges the tubing (e.g., 277 and 259) only whenthe drug-delivery end portion (e.g., 269) of the tubing (e.g., 277 and259) is stored in the storage site (e.g., 271) as determined from theoutput of the sensor (e.g., 226). This helps prevent inadvertent priming(i.e., air purging) of the tubing (e.g., 277 and 259) when thedrug-delivery end portion (e.g., 269) of the tubing (e.g., 277 and 259)is in fluid communication with the patient.

In the same or a different implementation of the drug-delivery assembly(e.g., 251 and 200), the tubing (e.g., 277 and 259) is operativelydisconnectable from the pump (e.g., 220) only when the drug-delivery endportion (e.g., 269) of the tubing (e.g., 277 and 259) is stored in thestorage site (e.g., 271) as determined from the output of the sensor(e.g., 226). This helps prevent free flow of the drug into the patientor the environment. In one variation, a pump-housing door (e.g., 201)pinches the operatively connected tubing (e.g., 277 and 259) against thepump (e.g., 220) so that pump action is required for drug flow and drugflow is shut off (i.e., there is no free flow) when the pump (e.g., 220)is not pumping. In this variation, the pump-housing door (e.g., 201) islocked and cannot be opened to remove the pinched tubing (e.g., 277 and259) unless the drug-delivery end portion (e.g., 269) of the tubing(e.g., 277 and 259) is stored in the storage site (e.g., 271) asdetermined from the output of the sensor (e.g., 226).

A second expression of the embodiment of FIGS. 24-40 is for adrug-delivery cassette assembly 251 including a drug-delivery-cassettemain board 253. A drug vial 250 is attachable to the cassette main board253. The cassette main board 253 has a deflectable drug-vial-site sensorbeam 267 which is disposed to be deflected by the drug vial 250 when thedrug vial 250 is attached to the cassette main board 253 and to beundeflected when the drug vial 250 is unattached to the cassette mainboard 253. The drug-vial-site sensor beam 267 is also referred to, inone construction, as a spike sensor beam 267. Other constructions areleft to the artisan.

In one example of the second expression of the embodiment of FIGS.24-40, the cassette main board 253 is attachable to and detachable froma procedure room unit (PRU) 200 (shown in FIGS. 41-57) having adrug-vial-in-place optical sensor 228 (see FIG. 44) disposed to senseonly one of the deflected drug-vial-site sensor beam 267 and theundeflected drug-vial-site sensor beam 267. In one variation, theprocedure room unit 200 controls flow of the drug from the drug vial 250based at least in part on the drug-vial-in-place optical sensor 228sensing or not sensing the drug-vial-site sensor beam 267.

In the same or a different example of the second expression of theembodiment of FIGS. 24-40, the drug vial 250 includes a drug-vial seal42, and the drug-delivery cassette assembly 251 also includes a spike261 having a spike tip 296 and a spike barb 184. When the drug vial 250is attached to the cassette main board 253, the drug-vial seal 42 isperforated by the spike tip 296 and held by the spike barb 184 and thedrug-vial-site sensor beam 267 pushes the drug vial 250 up against thespike barb 184. Such pushing up reduces drug wastage, as can beappreciated by those skilled in the art. Other examples are left to theartisan.

A third expression of the embodiment of FIGS. 24-40 is for adrug-delivery cassette assembly 251 including a drug-delivery-cassettespike 261. A drug vial 250 is attachable to the spike 261. The drug vial250 includes a drug-vial seal 42. The spike 261 has a spike tip 296 anda spike barb 184. When the drug vial 250 is attached to the spike 261,the drug-vial seal 42 is perforated by the spike tip 296 and held by thespike barb 184.

A fourth expression of the embodiment of FIGS. 24-40 is for adrug-delivery cassette assembly 251 including a luer 269, adrug-delivery-cassette spike 261, tubing 277 and 259, and adrug-delivery-cassette main board 253. The spike 261 includes adrug-vial-seal-perforating spike tip 296. The tubing 277 and 259 has adrug-receiving end, which is fluidly-connectable to andfluidly-disconnectable from the spike 261 and has a drug-delivery end,which is fluidly-connected to the luer 269. The spike 261 is attachableto and detachable from the cassette main board 253. This allows just thespike 261 to be disposed in a sharps container reducing overallsharps-waste volume and disposal fees, as can be appreciated by thoseskilled in the art.

A fifth expression of the embodiment of FIGS. 24-40 is for adrug-delivery cassette assembly 251 including a luer 269, tubing 277 and259, and a drug-delivery-cassette main board 253. The tubing 277 and 259has a drug-receiving end, which is fluidly-connectable to a drug vial250 containing a drug, and has a drug-delivery end, which isfluidly-connected to the luer 269. The cassette main board 253 has aluer-site base portion 271. The luer 269 is attachable to and detachablefrom the luer-site base portion 271. The luer-site base portion 271 hasa drip chamber 273 disposed to collect any of the drug, which exits theluer 269 when the luer 269 is attached to the luer-site base portion271. The luer-site base portion 271 is also referred to, in oneconstruction, as a T-site base 271. Other constructions are left to theartisan. In one example of the fifth expression of the embodiment ofFIGS. 24-40, the drug-delivery cassette assembly 251 also includes adrug-absorbent pad 273′ disposed in the drip chamber 273. Other examplesare left to the artisan.

A sixth expression of the embodiment of FIGS. 24-40 is for adrug-delivery cassette assembly 251 including a luer 269 and tubing 277and 259. The tubing 277 and 259 includes a coiled tube 259 and aflexible tube 277 fluidly-connected together. The flexible tube 277 hasa drug-receiving end, which is fluidly-connectable to a drug vial 250containing a drug, and the coiled tube 259 has a drug-delivery end,which is fluidly-connected to the luer 269. The coiled tube 259 isextendible by the user. In one example of the sixth expression of theembodiment of FIGS. 24-40, the coiled tube 250 includes a plurality ofcoils wherein adjacent coils are releasably adhered together. Thisarrangement allows the user to pull out only the length of coiled tube259 needed for use with a patient thus providing for improved tubingmanagement. In one variation, adjacent coils are thermally tackedtogether. In another variation, irradiation during sterilizationreleasably adheres together adjacent coils of the coiled tube 259. Inthe same or a different example, the coiled tube 259 has a smallerinside diameter than the flexible tube 277. This reduces drug wastageremaining in the tubing 277 and 259 after its use and expedites removalof air during an initial purge. Other examples are left to the artisan.

A seventh expression of the embodiment of FIGS. 24-40 is for adrug-delivery cassette assembly 251 including a drug-delivery-cassettemain board 253 which is removably attachable to a procedure room unit200 of a sedation delivery system 100 (or other type of medical effectorsystem 100′) and which includes a peristaltic pump cutout 254. In oneexample, of the seventh expression of the embodiment of FIGS. 24-40, thedrug-delivery cassette assembly 251 also includes a drug-deliveryflexible tube 277 having a substantially linear portion attached to themain board 253 and spanning the peristaltic pump cutout 254, wherein,when the main board 253 is attached to the procedure room unit 200, theportion of the flexible tube 277 is operatively connected to pumpfingers of a drug-delivery peristaltic pump of the procedure room unit200.

An eighth expression of the embodiment of FIGS. 24-40 is for adrug-delivery cassette assembly 251 including a drug-delivery-cassettemain board 253. The main board 253 has a top-left portion, a top-rightportion, a bottom-right portion and a bottom-left portion. The cassettemain board 253 is removably attachable to a procedure room unit 200 of asedation delivery system 100 (or other type of medical effector system100′). The main board 253 has a peristaltic pump cutout 254 disposedbetween the top-left and top-right portions. The main board 253 has anair-in-line sensor cutout 255 disposed between the top-right portion andthe bottom-right portion.

In one example of the eighth expression of the embodiment of FIGS.24-40, the drug-delivery cassette assembly 251 also includes adrug-delivery flexible tube 277 having a substantially linear firstportion attached to the top-left portion and the top-right portion ofthe main board 253 and spanning the peristaltic pump cutout 254 andhaving a substantially linear second portion attached to the top-rightportion and the bottom-right portion of the main board 253 and spanningthe air-in-line sensor cutout 255. When the main board 253 is attachedto the procedure room unit 200, the first portion of the flexible tube277 is operatively connected to pump fingers of a drug-deliveryperistaltic pump of the procedure room unit 200 and the second portionof the flexible tube 277 is operatively connected to an air-in-linesensor of the procedure room unit 200.

In the same or a different example of the eighth expression of theembodiment of FIGS. 24-40, the lower-left portion of the main board 253extends below the lower-right portion of the main board 253 defining apump-door-latch cutout extending to the right of the lower-left portionand below the lower-right portion of the main board 253.

In one application of any of the above-described expressions of FIGS.24-40, including examples, etc. thereof, the cassette main board 253 isdirectly attachable to a procedure room unit (PRU) 200 (shown in FIGS.41-57). Other applications are left to the artisan.

Any one or more of the above-described expressions of the embodiment ofFIGS. 24-40, including examples, etc. thereof can be combined with anyother one or more of the above-described expressions of the embodimentof FIGS. 24-40, including examples, etc. thereof, as can be appreciatedby those skilled in the art.

The following paragraphs present a detailed description of oneparticular enablement of the embodiment of FIGS. 24-40. It is noted thatany feature(s) of this particular enablement can be added to any of thepreviously-described expressions (including examples, etc. thereof) ofthe embodiment of FIGS. 24-40. In this enablement, the drug-deliverycassette assembly 251 is used in conjunction with a drug-deliveryinfusion pump assembly 220. In this enablement, drug-delivery cassetteassembly 251 is part of an integrated patient monitoring and sedationdelivery system (SDS) 100 (shown in FIG. 41) intended to administersedation drug(s) during brief procedures. The system uses a drugdelivery algorithm and an intravenous infusion peristaltic (or othertype) pump 220 (see FIG. 41), together with the drug-delivery cassetteassembly 251, to deliver drug(s) with variable rate infusion thatachieves and maintains a desired sedation effect.

As used herein, the term “proximal” refers to a location on thedrug-delivery cassette assembly 251 closest to the device using thedrug-delivery cassette assembly 251 and thus furthest from the patienton which the drug-delivery cassette assembly 251 is used. Conversely,the term “distal” refers to a location farthest from the device usingthe drug-delivery cassette assembly 251 and closest to the patient.

As shown in FIGS. 24-26, cassette 251 is comprised of a cassette mainboard 253 which in one example is molded of rigid thermoplastic having agenerally flat rectangular shape, with smooth rounded corners, andrectangular cutouts 254 and 255 designed to permit interface with aperistaltic pump 220 (see FIG. 41) and its sensor components (e.g., 226and 228 as shown in FIG. 44). In one employment, cassette 251, includingmain board 253 and components are single-patient-use components and aredisposable. Cassette main board 253 is comprised of a generally flatthin base designed with molded features to support fluid communicationtubes 277 and 259, reducer 281, spike system 272, and commercial luer269. Spike system 272 includes spike cap 263, spike 261, air vent filter295, and spike elbow 265.

Again referring to FIGS. 24-26, cassette main board 253 has a top face252 and a bottom face 260, which hold secure components assembled tocassette 251. Cassette main board 253 has a peristaltic pump cutout 254on the proximal side. Air-in-line sensor cutout 255 and a tube passage258 are apertures generally located on the sides of main board 253. Avisible arrow sign 289 is relief molded generally on the center of mainboard 253, and the arrow tip indicates the insert direction of cassette251 to the user. Alignment hole 287 is a round aperture through mainboard 253 used to help the user position and align cassette 251 in thepump 220 (see FIG. 41).

As illustrated in FIGS. 24-26, in one construction cassette main board253 is comprised of one reinforcement rib 256 on top face 252 andparallel reinforcement grooves 286 on bottom face 260 to increasestiffness of plastic molded structure 253 adjacent to pump cutout 254and air-in-line sensor cutout 255. Reinforcement rib 256 andreinforcement grooves 286 help to make main board 253 rigid for handlingand use purposes. Reinforcement rib 256 and reinforcement grooves 286are integrally molded as part of cassette main board 253.

As shown in FIGS. 24 and 26, cassette main board 253 has: (a) a coiledtube base 257 designed to hold coiled tube 259; (b) a T-site base 271 tohold luer 269; and (c) a spike bed 262 to accommodate spike system 272.Cassette main board 253 also includes gripper handle 285.

As illustrated on FIG. 26, gripper handle 285 is an integral part ofcassette main board 253, extending from the distal side to facilitateuser handling. Gripper handle 285 is shaped with smooth rounded cornersto make it easy and comfortable to hold. Parallel ribs 190 are molded onthe top surface of gripper handle 285, which function to give a firmnon-slip surface for gripping firmly while inserting or removingcassette 251 from the pump 220 (see FIG. 41).

As illustrated on FIGS. 24 and 26, the drug delivery system mounted oncassette 251 is comprised of a set of flexible tubes assembled in fluidcommunication. The tubing set includes (a) a coiled tube 259 and (b) aflexible tube 277. The drug system also is comprised of: (c) a reducer281; (d) a spike system 272 mounted to spike bed 262; and (e) acommercial luer 269 mounted on a T-site base 271. In one construction,all pieces are removably mounted in place for handling andtransportation purposes.

As shown on FIGS. 25 and 26, tube 277 is made of transparent flexibleplastic, such as commercially available pvc, with constant internal andexternal diameter cross section. Tube 277 is made of a flexibleresilient material to permit bending through passage 258 and to fit intoclips 279. Tube 277 is generally assembled to follow the cassetteexternal contour. Cassette 251 utilizes clips 279 and track wallretainers 291 to guide and route tube 277, generally keeping itscross-sectional diameter constant around the corners of cassette 251 andthrough passage 258. In one construction, not shown, the track wallretainers 291 are replaced by one or more additional clips 279.

As illustrated on FIGS. 25 and 26, tube 277 is part of the drug fluidcommunication system and connects at one end to (a) spike elbow 265 andat the other end to (b) reducer 281. Tube 277 connects into spike elbow265 on the bottom side of cassette 251. Then tube 277 makes a turn intothe transversal direction of cassette 251, extending from cassettebottom side 260 through tube passage 258. The opposite end of tube 277is connected into reducer 281 on the top side of cassette 251. Tube 277extends freely across cutouts 254 and 255. Tube 277 crosses air-in-linecutout 255 and peristaltic pump cutout 254.

As shown on FIGS. 24, 26 and 29, flexible tube 277 is held in place bymolded clips 279 located on cassette top face 252. Clips 279 havealternating openings to keep tube 277 aligned and secured in placewithout distortion. Clips 279 are generally curved to match the outsidediameter of tube 277. Clip openings 270 and 276 are the result of themanufacturing process that creates the clips. Double clips 280 securereducer 281 on cassette main board 253. In one construction, doubleclips 280 are built with only a small clearance between them (as shownon FIG. 29) to attach firmly to reducer 281 and anchor the tubingsystem. Clips 280 also have a curved shape to match the outside contourof reducer 281 body. Double clips 280 keep the two rings on the body ofreducer 281 restrained in a fixed position, preventing sliding duringhandling or use. The reducer 281 has a flat bottom, and the cassettemain board 253 has a reducer-positioning rib 40 (seen in FIG. 29 butomitted from FIG. 26 for clarity), which also helps the reducer 281 stayin position when the reducer 281 is secured by double clips 280. In oneexample, tube 277 is kept firm and straight after connection to aperistaltic pump 220, which is accomplished by clips 280.

As illustrated on FIGS. 26 and 29, track wall retainers 291 are moldedon cassette top face 252 to trap and keep constrained tube 277 as it isrouted around corners. The distance between walls is such that itcreates a slight interference with tube 277 helping to retain tube 277.As previously mentioned, in one construction, not shown, the track wallretainers 291 are replaced by one or more additional clips 279.

As shown on FIG. 26, reducer 281 is part of the fluid communicationsystem, and is mounted onto the proximal part of cassette 251. In oneconstruction, it is made of transparent thermoplastic material andcomprises an inlet and outlet in fluid communication, with the inlet andoutlet at approximately right angles to each other. The inlet end ofreducer 281 is larger than the outlet. The outlet end is adapted to beconnected to IV (intravenous) coiled tube 259 while the inlet end isadapted to connect to flexible tube 277. Reducer 281 main body isgenerally cylindrical shaped with two molded rings to mount onto clips280 to keep it fixed in place. Reducer 281 also helps secure smallerdiameter tubing assembly coiled tube 259 and larger diameter flexibletube 277 in place.

As illustrated on FIGS. 26 and 27, coiled tube 259 is made oftransparent IV tubing, for example commercially available pvc,manufactured and assembled to be biased into a generally cylindricalspiral as a way to minimize overall size and to facilitate handling andmanagement by the user. In one construction, coiled tube 259, whenuncoiled and extended to its maximum length, would total approximately 8feet. This would be a sufficient length for the user to extend coiledtube 259 between cassette 251 and the patient. In one construction,coiled tube 259 is stored on cassette 251 in a half-cylindrical shapebase 257 designed to prevent movement during cassette 251 shipping andinstallation into the pump 220. One end of coiled tube 259 is affixed toreducer 281 while the other end is connected to luer 269. In use, theclinician removes luer 269 from T-site bed 271, disconnecting luer 269from first luer clip 274 and second luer clip 297, and pulls and uncoilstube 259 as far as necessary to reach the patient. It should be notedthat the inside fluid path of tube 259 is minimized as compared withflexible tube 277 so as to minimize wasted drug(s) remaining in thetubing after its use and to expedite removal of air during an initialpurge.

As shown on FIGS. 24, 27 and 29-31, T-site base 271 is designed toremovably capture luer 269. T-site base 271 also includes a deflectivebuilt-in beam 275, which contacts luer 269 when luer 269 is fixed inplace, causing beam 275 to deflect and interface with an optical sensor226 on the Procedure Room Unit (PRU) 200 (shown in FIGS. 41-57). T-sitebase 271 further includes open drip chamber 273 used as a reservoir tocapture and contain drug spillage during drug line purge. T-site base271 has built-in walls to create a sloped bed (as shown on FIG. 35) oncassette top face 252. T-site base 271 has two molded-in clips. Firstluer clip 274 and second luer clip 297 firmly secure luer 269. T-sitebase 271 includes a thin tower 278. Luer 269 lays on top of T-site tower278 at an inclined angle to direct excess drug spillage into chamber273.

As illustrated on FIGS. 27 and 29, drip chamber 273 is integrally partof T-site base 271 and in one example is a molded part of cassette mainboard 253. Drip chamber 273 is generally located in a central area ofcassette main board 253. Drip chamber 273 has a generally rectangularshape with one wall congruent to T-site tower 278 and is sized tocontain a specific volume of the total drug vial 250 (see FIG. 32)content. Drip chamber 273 functions to prevent spillage during drug linepurge and to capture any residual drug after cassette use. In onevariation, drip chamber 273 contains an absorbent pad 273′ to absorb alldrained drug(s).

As shown on FIGS. 25-27 and 29-31, T-site sensor beam 275 is molded asan integral part of cassette main board 253 and acts as a cantileverbeam. The pivot point of beam 275 is built in the distal side ofcassette 251 on the top face of T-site tower 278. In one construction,the free hanging end of beam 275 extends through cassette bottom face260 into a central longitudinal opening of T-site base 262 (as shown onFIG. 31), which interfaces with T-site-in-place optical sensor 226located on the PRU 200. The free hanging end of beam 275 is generallydesigned as a “T”. One tip of the “T” touches luer 269. When luer 269 issecured in base 271, beam 275 deflects and the other T tip breaks thelight beam of the optical T-site-in-place sensor 226. This indicates tothe PRU 200 (shown in FIGS. 41-57) that luer 269 is in place so thatdrug line purge can be performed.

As illustrated on FIGS. 26 and 27, luer 269 is commercially availableand well known in the medical arts. It is made of rigid plastic. In oneconstruction, luer 269 is “T” shaped with an internal lumen in fluidcommunication with all three legs of the “T”. One T-leg connects tocoiled tube 259. Another “T” leg contains a needleless port that can beattached to IV luer fitting. The last “T” leg has a removable dust cap.

As shown on FIGS. 26, 28 and 32-34, spike bed 262 is a recessed areamolded into cassette main board 253 at a slight angle so that when spike261 is assembled to main board 253, spike 261 is substantiallyvertically oriented when cassette 251 is placed into the pump 220 in thePRU 200 (shown in FIGS. 41-57). The vertical position of spike 261 helpsthe drug vial 250, when placed on spike 261, to drain properly andcompletely. Spike bed 262 has upright walls to accommodate spike wing197. Spike bed 262 bottom includes two guiding pins 299 extendingupwards and two apertures 292 to help in aligning spike assembly 261.The center area of spike bed 262 has a half-cylindrical base 199 toaccommodate air-vent boss 177. The air-vent boss base 199 generallycreates a step on the round contour to hold hollow spike 261 in place.In the center of spike bed 262 bottom there is a round aperture forinserting spike drug boss 185. In the longitudinal direction, in themiddle of spike bed 262, is the cutout of spike sensor beam 267, whichhas a flat curved shape. Spike sensor beam 267 is fixed at the proximalside of spike bed 262, and is a cantilever beam.

As shown on FIGS. 29-34, cantilever spike sensor beam 267 (shown on FIG.30), is an integral part of cassette main board 253. At the extreme endof spike beam 267 is lower spike tab 290, which is positioned tointerface with an optical vial-in-place sensor 228 located on the PRU200 pump 220 (shown in FIG. 41). Upper spike tab 288 is a second tablocated in an intermediate position along beam 267 and is positioned tointerface with a drug vial 250 when a drug vial 250 is placed on spike261. Upper spike tab 288 extends through aperture 198 on spike wing 197when spike 261 is properly assembled to cassette main board 253. Whencassette assembly 251 is in place in the pump 220 on the PRU 200 (shownin FIGS. 41-57) and when a drug vial 250 is placed on spike 261, thevial makes contact with upper spike tab 288 causing spike sensor beam267 to deflect sufficiently to cause lower spike tab 290 to interfacewith optical vial-in-place sensor 228 located on the PRU 200. Thisindicates to the PRU 200 that a drug vial 250 is properly in place sothat drug line purge can be performed and so that the PRU 200 pump 220can deliver drug(s) to the patient.

As shown on FIGS. 24, 26 and 32-34, spike system 272 is comprised ofspike cap 263, spike 261, and spike elbow 265. Spike cap 263 helpsprotect clinicians from inadvertent sticks by spike tip 296. Spike cap263 is removably attached on top of spike tip 296 by a latchingmechanism. Spike elbow 265 is removably threaded (with a luer lock) ontodrug boss 185. Spike elbow 265 securely attaches spike 261 to cassettemain board 253. Unthreading spike elbow 265 from drug boss 185 allowsspike 261 to be easily removed from cassette main board 253 so thatspike 261 can be properly disposed in a sharps container, minimizingoverall waste volume, and saving disposal fees for the user.

As illustrated on FIGS. 32-34, spike 261 is molded of rigidthermoplastic material and contains two internal lumens runninggenerally parallel the length of spike 261. Spike 261 is generallycylindrical, having a perforating tip 296 and a spike wing 197 thatserves as a base to spike tip 296. Spike 261 includes spike barb 184that will prevent a drug vial 250 from slipping off of spike tip 296.Spike tip 296 includes a first bevel 186 and a second bevel 187. Firstbevel 186 includes a drug opening, which is in fluid communication withdrug line lumen 195. Similarly, second bevel 187 includes an air-vialopening, which is in airway communication with air-vent lumen 196. Inuse, a drug vial bottle seal 42 is perforated by spike tip 296 and heldby spike barb 184.

As shown on FIGS. 26 and 32-34, drug line lumen 195 is in fluidcommunication between spike tip 296 and drug channel 294. External todrug channel 294 is drug boss 185. On the outside of drug boss 185 isthread 193 for attaching spike elbow 265. Air-vent lumen 194 is in fluidcommunication with air-vent channel 293. External to air-vent channel293 is air-vent boss 177. Air-vent lumen 194 is used to equalize the airpressure inside the drug vial 250, permitting fluid to flow by gravityfrom the drug vial 250 through drug line lumen 195 into the drug tubingline. In one construction, there is an air-vent filter 295 (as shown onFIG. 26), commercially available, that snaps into air-vent boss 177.Generally air-vent filter 295 has a cylindrical shape with a fine meshfeature on one side. Air-vent filter 295 is permeable to passage ofgases, including air, in either direction though the air-vent channel293, but precludes passage of liquid and solid materials in eitherdirection through air-vent channel 293.

As shown on FIGS. 26, 28, 32-40, spike 261 has a flat wing 197 basedesigned as a generally trapezoidal thin plate, with smooth roundcorners. The flat thin shape of spike wing 197 facilitates user handlingand creates support for spike cap 263. Two spike apertures 191 arecoincident with spike base apertures 292 and serve to align the spike261 to the vial centering mechanism in the PRU 200. Spike alignmentapertures 298 are used for alignment when inserting spike 261 oncassette 251 and engages through spike pins 299, to align spike 261 onspike bed 262.

As shown on FIGS. 32-40, spike 261 includes snap lock 189 on top ofspike wing 197. Snap lock 189 is integrally formed from spike wing 197.Snap lock 189 interfaces with spike latch 284 located on spike cap 263to retain spike cap 263 on spike 261.

As illustrated on FIGS. 24 and 32-40, spike cap 263 is made of rigidthermoplastic and is a safety protection device for spike system 272.Spike cap 263 includes covering head 176, which is a hollow body, usedto cover spike tip 296. Spike hollow 181 has a generally oblong shapeand facilitates the assembly of spike cap 263 over spike tip 296. Spikecap 263 includes cap handle 182 to facilitate easy handling by the user.On each side of cap handle 182 are located gripper ribs 178. A latchingmechanism includes spike latch 284 and two supporting arms, first arm179 and second arm 180, molded integrally on both sides of covering head176. Spike latch 284 has a spring-like property and is capable ofdeflecting normal to the axis of covering head 176. When spike cap 263is assembled over spike tip 296, latch 284 is deflected by snap lock 189located on spike 296, causing lip 183 to lock onto the edge of snap lock189. First arm 179 and second arm 180 prevent spike cap 263 fromtilting. As shown in FIGS. 24, 26, 28-31, the cassette main board 253includes two cap-attaching ribs 38 which provide for a removablesnap-fit attachment therebetween of the cap handle 182 of the spike cap263 to the cassette main board 253. A brisk, quick upward force on caphandle 182 will cause spike cap 263 to release from spike 261 and fromcap-attaching ribs 38.

As shown on FIGS. 25 and 26, spike elbow 265 is made of a rigidthermoplastic and is generally cylindrical in shape with two openingsconnected by internal fluid channel 264. One opening of fluid channel264 connects to tube 277. The other opening of channel 264 is in fluidcommunication with drug channel 294 located in spike 261, and permitsdrug(s) to flow by gravity from a spiked vial through drug lumen 195,and through to tube 277. Spike elbow 265 includes an internally threadedring to permit spike elbow 265 to be removably attached to spike boss185 (See FIG. 33). When spike 261 is properly assembled to cassette mainboard 253, spike elbow retains spike 261.

Drug delivery cassette 251 is for single patient use (SPU) and ismanually loaded in a pump cassette deck 219 on a Procedure Room Unit(PRU) 200 (shown in FIGS. 41-57). The pump cassette deck 219 has ahinged door that serves to press cassette 251 against the peristalticpump 220. Cassette 251 contains intravenous tubing that is connected toa patient's catheter.

Procedure Room Unit

A third aspect of the invention is directed to, or a component of, orcan be used by, a procedure room unit 200, an embodiment of which isshown in FIGS. 41-57. A first expression of the embodiment of FIGS.41-57 is for a drug-delivery infusion pump assembly 220 including adrug-delivery infusion pump housing 239, a drug-delivery cassetteassembly 251 (an embodiment of which has been previously discussed andshown in greater detail in FIGS. 24-40), and a pump-housing door 201.The drug-delivery cassette assembly 251 is attachable to the infusionpump housing 239 and has a drug-vial spike 261 (See FIG. 32). Thepump-housing door 201 is attached to the infusion pump housing 239, hasdoor-open and door-closed positions, and has drug-vial-aligning fingers44. The drug-vial-aligning fingers 44 center and align differentdiameter drug vials 250 when: the cassette assembly 251 is attached tothe infusion pump housing 239; the pump-housing door 201 is in thedoor-closed position; and a drug vial 250 is inserted between thedrug-vial-aligning fingers 44 for engagement with the spike 261.

In one construction of the first expression of the embodiment of FIGS.41-57, the drug-vial-aligning fingers 44 center and align ten and twentycubic-centimeter drug vials 250 having different outside diameters andhaving the same or different lengths. In one variation, thedrug-vial-centering fingers 44 consist essentially of two resilient,concave and opposing fingers. In the same or a different construction,the pump-housing door 201 is rotatably attached to the infusion pumphousing 239 and is rotatable between the door-open and door-closedpositions. Other constructions and variations are left to the artisan.

In one example of the first expression of the embodiment of FIGS. 41-57,the cassette assembly 251 is attachable to, and removable from, theinfusion pump housing 239 when the pump-housing door 201 is in thedoor-open position. In the same or a different example, thedrug-delivery infusion pump assembly 220 also includes a drug-deliveryperistaltic pump 232 disposed in the infusion pump housing 239 andhaving pump fingers 229. In this example, the cassette assembly 251 isoperatively connectable to the pump fingers 229 when the cassetteassembly 251 is attached to the infusion pump housing 239 and thepump-housing door 201 is in the door-open position.

In one application of the first expression of the embodiment of FIGS.41-57, the drug-delivery infusion pump assembly 220 is a part of aprocedure room unit (PRU) 200 of a sedation delivery system (SDS) 100(or other type of medical effector system 100′) wherein the SDS 100 (orother type of medical effector system 100′) also has a bedsidemonitoring unit (BMU) 300 and an umbilical cable 160. In thisapplication, the BMU 300 has a first series of connection points forreceiving input signals from patient monitoring connections and a secondseries of connection points for outputting patient parameters and has adisplay screen for displaying patient parameters. In this application,the PRU 200 is used during a medical procedure and for receiving patientparameters from the BMU 300 and has a display screen for displayingpatient parameters. In this application, the umbilical cable 160 is usedfor communicating patient parameters from the BMU 300 to the PRU 200.

A second expression of the embodiment of FIGS. 41-57 is for adrug-delivery infusion pump assembly 220 and drug-delivery cassetteassembly 251 combination including a drug-delivery infusion pump housing239, a drug-delivery cassette assembly 251, a pump-housing door 201, anda pump-housing door lock 205/222. The cassette assembly 251 isattachable to the infusion pump housing 239, has a luer 269, and has adrug-delivery-cassette main board 253 including a luer-site base portion271. The luer 269 is attachable to and detachable from the luer-sitebase portion 271. The pump-housing door 201 is attached to the infusionpump housing 239 and has door-open and door-closed positions. Thepump-housing door lock 205/222, when the cassette assembly 251 isattached to the infusion pump housing 239, unlocks the pump-housing door201 when the luer 269 is attached to the luer-site base portion 271.

In one enablement of the second expression of the embodiment of FIGS.41-57, the lock 205/222 includes a pump-door latch 205 and a door latchsolenoid 222 operatively connected to the pump-door latch 205. Otherenablements are left to the artisan. It is noted that the pump-housingdoor 201 can be opened to remove the cassette assembly 251 when the luer269 is returned to the luer-site base portion 271 at the end of amedical procedure.

A third expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) including a capnometer140 and 202 and a barcode reader assembly 455. The capnometer 140 and202 is adapted to receive directly or indirectly respiratory gasobtained from a single-patient-use cannula 351′ which is disposable onthe face of a patient. The barcode reader assembly 455 is adapted toread a barcode of a package containing the cannula 351′ and/or a barcodeof the cannula 351′.

An additional third expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) including adrug-delivery infusion pump housing 239 and a barcode reader assembly455. The drug-delivery infusion pump housing 239 is adapted to receive asingle-patient-use drug-delivery cassette assembly 251. The barcodereader assembly 455 is adapted to read a barcode of a package containingthe drug-delivery cassette assembly 251 and/or a barcode of thedrug-delivery cassette assembly 251.

In a further third expression of the embodiment of FIGS. 41-57, thecassette assembly 251 is adapted to receive a single-patient-use drugvial 250 containing a drug (such as, but not limited to, a sedationdrug), and the barcode reader assembly 455 is adapted to read a barcodeof the drug vial 250 and/or a barcode of a package containing the drugvial 250.

In one employment of the third expression, the additional thirdexpression and/or the further third expression of the embodiment ofFIGS. 41-57, the procedure room unit 200 uses the barcode readerassembly 455 to prevent multiple use of a single-patient-use item suchas the drug-delivery cassette assembly 251, the cannula 351 ′, and thedrug vial 250 in the procedure room unit 200. In another employment, theprocedure room unit 200 uses the barcode reader assembly 455 to matchsingle-patient-use items to a particular patient. Other employments areleft to the artisan.

A fourth expression of the embodiment of FIGS. 41-57 is for a sedationdelivery system 100 (or other type of medical effector system 100′)including a microprocessor-based bedside monitoring unit 300, amicroprocessor-based procedure room unit 200, and an umbilical cable160. The bedside monitoring unit 300 has a first series of connectionpoints for receiving patient inputs from patient monitoring connections,has a second series of connection points for outputting patient outputsbased on the received inputs, and has a display screen for displaying atleast some of the patient outputs. The procedure room unit 200 has adrug-delivery flow control assembly 220′ (or other type of medicaleffector 220″), and has a host controller 204 with a memory containing apatient-monitoring and drug-delivery-scheduling program (or other typeof patient-monitoring and medical-effector scheduling program). Theprogram is operatively connected to program inputs based at least inpart on at least some of the patient outputs, and the program controls,and/or advises a user to control, the drug-delivery flow controlassembly 220′ (or other type of medical effector 220″) based at least inpart on the program inputs. The umbilical cable 160 has a first endattached or attachable to the second series of connection points of thebedside monitoring unit 300 and has a second end attached or attachableto the procedure room unit 200. At least one of the first and secondends of the umbilical cable 160 is detachable from the correspondingbedside monitoring unit 300 or the procedure room unit 200. Theprocedure room unit 200 includes an Ethernet and/or a modem connector471/470 operatively connected to the host controller 204.

In one arrangement of the fourth expression of the embodiment of FIGS.41-57, the drug-delivery flow control assembly 220′ includes adrug-delivery infusion pump assembly 220 such as a peristaltic pumpassembly. In one variation of this arrangement, the drug(s) is deliveredto the patient through an IV. In another arrangement, not shown, thedrug-delivery flow control assembly includes a gaseous-drug gas flowcontroller. In one variation of this arrangement, the gaseous drug(s) isoxygen and/or a non-oxygen gas and is delivered to the patient through acannula assembly.

In one employment of the fourth expression of the embodiment of FIGS.41-57, the Ethernet and/or modem connector 471/470 is used for remotesoftware updates of programs residing in the memory of the hostcontroller 204 of the procedure room unit 200, such as thepatient-monitoring and drug-delivery-scheduling program (or other typeof patient-monitoring and medical-effector-scheduling program). The term“memory” includes all memory of the host controller 204 including, inone example, all memory of the system input/output board 451 of the hostcontroller and all memory of the processor board 452 of the hostcontroller. In the same or a different employment, the host controller204 of the procedure room unit 200 uses the Ethernet and/or modemconnector 471/470 to send patient data to a remote computer for datamanagement purposes. Other employments are left to the artisan. In oneconstruction, the procedure room unit 200 has only an Ethernet connector471 and not a modem connector 470. In a different construction, only amodem interface 470 and not an Ethernet interface 471 is present. Inanother construction, both an Ethernet and a modem interface 471 and 470are present. In one enablement of the fourth expression of theembodiment of FIGS. 41-57, the procedure room unit 200 includes amonitor display 442 for displaying at least some of the program inputsand the status of the drug-delivery flow control assembly 220′ (or othertype of medical effector 220″).

A fifth expression of the embodiment of FIGS. 41-57 is for a sedationdelivery system 100 (or other type of medical effector system 100′)including a microprocessor-based bedside monitoring unit 300, amicroprocessor-based procedure room unit 200, and an umbilical cable160. The bedside monitoring unit 300 has a first series of connectionpoints for receiving patient inputs from patient monitoring connections,has a second series of connection points for outputting patient outputsbased on the received inputs, and has a display screen for displaying atleast some of the patient outputs. The procedure room unit 200 has adrug-delivery flow control assembly 220′ (or other type of medicaleffector 220″), and has a host controller 204 with a memory containing apatient-monitoring and drug-delivery-scheduling program (or other typeof patient-monitoring and medical-effector-scheduling program). Theprogram is operatively connected to program inputs based at least inpart on at least some of the patient outputs. The program controls,and/or advises a user to control, the drug-delivery flow controlassembly 220′ (or other type of medical effector 220″) based at least inpart on the program inputs. The umbilical cable 160 has a first endattached or attachable to the second series of connection points of thebedside monitoring unit 300 and has a second end attached or attachableto the procedure room unit 200. At least one of the first and secondends of the umbilical cable 160 is detachable from the correspondingbedside monitoring unit 300 or the procedure room unit 200. The hostcontroller 204 of the procedure room unit 200 includes Health LevelSeven application protocol to electronically send and/or receivecommunications to and/or from a remote computer.

In one employment of the fifth expression of the embodiment of FIGS.41-57, the Health Level Seven application protocol is used toelectronically send patient data to a remote computer for datamanagement purposes. In the same or a different employment, the HealthLevel Seven application protocol is used to electronically receiveremote servicing of (such as running remote diagnostic programs on) theprocedure room unit 200. Other applications are left to the artisan.

A sixth expression of the embodiment of FIGS. 41-57 is for a sedationdelivery system 100 (or other type of medical effector system 100′)including a microprocessor-based bedside monitoring unit 300, amicroprocessor-based procedure room unit 200, and an umbilical cable160. The bedside monitoring unit 300 has a first series of connectionpoints for receiving patient inputs from patient monitoring connections,has a second series of connection points for outputting patient outputsbased on the received inputs, and has a display screen for displaying atleast some of the patient outputs. The procedure room unit 200 has adrug-delivery flow control assembly 220′ (or other type of medicaleffector 220″), and has a host controller 204 with a memory containing apatient-monitoring and drug-delivery-scheduling program (or other typeof patient monitoring and medical-effector-scheduling program). Theprogram is operatively connected to program inputs based at least inpart on at least some of the patient outputs. The program controls,and/or advises a user to control, the drug-delivery flow controlassembly 220′ (or other type of end effector 220″) based at least inpart on the program inputs. The umbilical cable 160 has a first endattached or attachable to the second series of connection points of thebedside monitoring unit 300 and has a second end attached or attachableto the procedure room unit 200. At least one of the first and secondends of the umbilical cable 160 is detachable from the correspondingbedside monitoring unit 300 or the procedure room unit 200. Theprocedure room unit 200 includes a printer 454 operatively connected tothe host controller 204.

In one employment of the sixth expression of the embodiment of FIGS.41-57, the printer 454 is used to create a printed patient record of therole of the sedation delivery system 100 (or other type of medicaleffector system 100′) during the medical procedure undergone by thepatient. In one example of the sixth expression of the embodiment ofFIGS. 36-52, the procedure room unit 200 includes a procedure-room-unitconsole 444, wherein the console 444 contains the drug-delivery flowcontrol assembly 220′ (or other type of medical effector 220″), the hostcontroller 204, and the printer 454. In one construction, the printer454 is a thermal printer.

A seventh expression of the embodiment of FIGS. 41-57 is for a sedationdelivery system 100 comprising a microprocessor-based bedside monitoringunit 300, a microprocessor-based procedure room unit 200, and anumbilical cable 160. The bedside monitoring unit 300 has abedside-monitoring-unit host controller 301 (See FIG. 62), whichcontains a first program. The first program performs the steps of:issuing a request to a non-sedated patient for a non-sedated patientresponse; receiving a signal based on the non-sedated patient response;and calculating a non-sedated response time for the patient based atleast in part on a time difference between issuing the request andreceiving the signal. The procedure room unit 200 has aprocedure-room-unit host controller 204, which contains a secondprogram. The second program performs the steps of: issuing requeststhrough the bedside monitoring unit 300 to a sedated patient for asedated patient response; receiving a signal through the bedsidemonitoring unit 300 based on the sedated patient response; calculating asedated response time for the sedated patient, and calculating aresponse time difference between the non-sedated and sedated responsetimes. The umbilical cable 160 has a first end attached or attachable tothe bedside monitoring unit 300 and has a second end attached orattachable to the procedure room unit 200. At least one of the first andsecond ends is detachable from the corresponding bedside monitoring unit300 or the procedure room unit 200.

In one example of the seventh expression of the embodiment of FIGS.41-57, the procedure room unit 200 has a drug-delivery infusion pumpassembly 220. The drug-delivery infusion pump assembly 220 is controlledby the procedure-room-unit host controller 204 based at least in part onthe response time difference. In the same or a different example, thesedation delivery system 100 includes a cannula assembly 145 disposableon the face of a patient and having a respiratory gas sampling tube 354,352 and 355 (See FIG. 1). The respiratory gas sampling tube 354, 352 and355 (See FIG. 1) is connectable to the bedside monitoring unit 300. Theprocedure room unit 200 includes a capnometer 202 and 140 having acapnometer output signal, and the umbilical cable 160 is operativelyconnectable to the respiratory gas sampling tube 354, 352 and 355 andthe capnometer 202 and 140. The drug-delivery infusion pump assembly 220is controlled at least in part by the capnometer output signal.

In one employment of the seventh expression of the embodiment of FIGS.41-57, the bedside monitoring unit 300 uses an audio earpiece 362 (SeeFIG. 1) to provide the patient 10 with requests to squeeze anautomated-responsiveness-monitor (ARM) handset 342 (e.g., a handpiecewhich, in one illustration includes a vibrator to also request aresponse from the patient) to calculate patient response times. Therequests are issued by the bedside monitoring unit 300 in apre-procedure room to train the non-sedated patient to use the ARMhandset 342 and to calculate the non-sedated response time. The requestsare issued by the procedure room unit 200 (and transmitted to thebedside monitoring unit 300 through the umbilical cable 160) when thepatient undergoes sedation in the procedure room to calculate sedatedresponse times throughout the procedure. The requests are issued by thebedside monitoring unit 300 in a post-procedure room to present YES/NOquestions, multiple choice questions, time-based responsiveness queriesor other such prompt/reply interactions and combine the responses withother monitored parameters to conduct patient assessment. An examplewould be a series of questions/activities to show cognitive and motorfunctions prior to patient discharge. A further example would be tomonitor the level of responsiveness and alerting the appropriate medicalstaff if the patient does not reach certain defined thresholds within anappropriate period of time.

A still further example would be to utilize the ARM handset 342 in placeof a call button. While patients are in the pre-procedure orpost-procedure room, a long squeeze or rapid squeezes on ARM handset 342would be detected by BMU 300 as a request for assistance. BMU 300 wouldthen log the request, post it on the BMU GUI 212 (See FIG. 60) andilluminate the light bar 208 (See FIG. 60) in an appropriate color orflashing scheme.

A further example is BMU 300 detecting a low respiration rate, apneacondition, or low SpO₂ and communicating this status to the patient. BMU300 would send an audio request, such as “TAKE A DEEP BREATH” to thepatient by way of audio earpiece 362, instructing the patient to take adeep breath. The command may be repeated at a predetermined timeinterval if the patient's respiration rate does not increase.Furthermore, the command may be initially provided at a first nominalvolume level, and subsequent commands are provided at a second volumelevel, higher than said first volume level. If the patient does notrespond to the request for respiration, an alarm will alert the careteam of the patient's condition. Other similar type of audio commandsmay be given to the patient as other conditions warrant a specificpatient response.

An eighth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) comprising aprocedure-room-unit host controller 204 which contains an oxygendelivery program which performs the steps of: receiving a pulse-oximetersignal from a patient undergoing sedation and calculating an oxygen flowrate based at least in part on the received pulse-oximeter signal,wherein the procedure-room-host controller 204 controls a flow of oxygento the patient based on the calculated oxygen flow rate.

In the eighth expression of the embodiment of FIGS. 41-57, the oxygenflow rate to the patient is variable and is based at least in part onpatient blood oxygen levels from the received pulse-oximeter signal. Itis noted that the term “oxygen”, when describing oxygen delivery,includes air with an enriched oxygen content.

A first extension of the eighth expression of the embodiment of FIGS.41-57 is for a sedation delivery system 100 (or other type ofmedical-effector system 100′) including the sedation-delivery-systemprocedure room unit 200 (or other type of medical-effector-systemprocedure room unit 200′) as described in the previous paragraph,including a bedside monitoring unit 300, and including an umbilicalcable 160. The umbilical cable 160 has a first end attached orattachable to the bedside monitoring unit 300 and has a second endattached or attachable to the procedure room unit 200. At least one ofthe first and second ends is detachable from the corresponding bedsidemonitoring unit 300 or the procedure room unit 200. When the umbilicalcable 160 is attached to the procedure room unit 200 and the bedsidemonitoring unit 300, the pulse-oximeter signal flows from the patientthrough the bedside monitoring unit 300 and through the umbilical cable160 to the procedure room unit 200 and the flow of oxygen flows throughthe umbilical cable 160 and the bedside monitoring unit 300 to thepatient.

A ninth expression of the embodiment of FIGS. 41-57 is for medicaloxygen-delivery apparatus including an oxygen-delivery manifold 206having an oxygen-delivery flow path, a fixed-size-orifice flowrestrictor 489, and a variable-size-orifice flow restrictor 480. Theoxygen-delivery flow path includes a flow-path inlet fluidly-connectableto a source of pressurized oxygen and a flow-path outletfluidly-connectable to a cannula 351′ disposable on the face of apatient. The fixed-size-orifice flow restrictor 489 is disposed in theflow path downstream of the flow-path inlet, and thevariable-size-orifice flow restrictor 480 is disposed in the flow pathdownstream of the fixed-size-orifice flow restrictor 489.

In one example of the ninth expression of the embodiment of FIGS. 41-57,the medical oxygen-delivery apparatus also includes a high side pressuresensor 487 in fluid communication with the flow path at a first locationdisposed between the flow-path inlet and the fixed-size-orifice flowrestrictor 489 and includes a differential pressure sensor 479 in fluidcommunication with the flow path at an entrance location disposedbetween the first location and the fixed-size-orifice flow restrictor489 and at an exit location disposed between the fixed-size-orifice flowrestrictor 489 and the variable-size-orifice flow restrictor 480. Theorifice size of the variable-size-orifice flow restrictor 480 is relatedto the measured pressure and pressure difference and is used to controlthe flow rate as is within the routine capabilities of those skilled inthe art. In the same or a different example, the variable-size-orificeflow restrictor 480 is a variable-size-orifice solenoid. In oneapplication, the oxygen-delivery manifold 206 is a subassembly of aprocedure room unit 200 of a sedation delivery system 100 (or other typeof medical effector system 100′).

A tenth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or othermedical-effector-system procedure room unit 200′) including aprocedure-room-unit host controller 204, which contains an oxygendelivery program. The program performs the steps of: controlling thedelivery of oxygen at a predetermined first rate to at least onerespiratory-gas-delivery oral prong 369″/371″ of a cannula assembly 145operatively connected to a patient, when the patient is determined to beinhaling and exhaling through the mouth; controlling the delivery ofoxygen at a predetermined second rate to at least onerespiratory-gas-delivery nasal prong 422′ and 422″ of the cannulaassembly 145 when the patient is determined to be breathing through thenose and when the patient is determined to be inhaling; and controllingthe delivery of oxygen at a predetermined third rate to the at-least-onerespiratory-gas-delivery nasal prong 422′ or 422″ when the patient isdetermined to be breathing through the nose and when the patient isdetermined to be exhaling. The second rate is higher than the thirdrate.

In one example of the tenth expression of the embodiment of FIGS. 41-57,when oxygen flows, oxygen always flows to all respiratory-gas-deliveryoral and nasal prongs when the rate of oxygen delivery is beingcontrolled to either the respiratory-gas-delivery oral or nasal prongs.

In one enablement of the tenth expression of the embodiment of FIGS.41-57, the oxygen delivery program also performs the steps ofdetermining that the patient is breathing through the nose or the mouthand, if through the nose, that the patient is inhaling or exhaling basedat least in part on nasal pressure readings from sampled respiratory gastaken from at least one respiratory-gas-sampling nasal prong 364 and 365of the cannula assembly 145.

A first alternate tenth expression of the embodiment of FIGS. 41-57 isfor a medical-effector-system procedure room unit 200′ (such as asedation-delivery-system procedure room unit 200′) including aprocedure-room-unit host controller 204 which contains an oxygendelivery program. The program performs the steps of: controlling thedelivery of oxygen at a variable first rate to at least onerespiratory-gas-delivery oral prong 369″/371″ of a cannula assembly 145operatively connected to a patient, when the patient is determined to beinhaling and exhaling through the mouth; controlling the delivery ofoxygen at a variable second rate to at least onerespiratory-gas-delivery nasal prong 422′ and 422″ of the cannulaassembly 145 when the patient is determined to be breathing through thenose and when the patient is determined to be inhaling; and controllingthe delivery of oxygen at a variable third rate to the at-least-onerespiratory-gas-delivery nasal prong 422′ and 422″ when the patient isdetermined to be breathing through the nose and when the patient isdetermined to be exhaling. The patient has a variable percentage ofblood oxygen saturation, and the first, second and third rates depend onthe percentage of blood oxygen saturation.

In one enablement of the first alternate tenth expression of theembodiment of FIGS. 41-57, the second rate is a fixed low rate forpercentages of blood oxygen saturation above a predetermined highpercentage and is a fixed high rate for percentages of blood oxygensaturation below a predetermined low percentage. In one variation, thesecond rate steps up a plurality of times from the fixed low rate to thefixed high rate as the percentage of blood oxygen saturation decreasesfrom the predetermined high percentage to the predetermined lowpercentage. In one modification, the second rate is higher than thethird rate for the same percentage of blood oxygen saturation. In oneimplementation, the third rate is zero at the predetermined highpercentage. In the same or a different enablement, the first ratecorresponding to a particular percentage of blood oxygen saturation isthe arithmetic mean of the second and third rates corresponding to theparticular percentage of blood oxygen saturation. In the same or adifferent enablement, the oxygen delivery program accepts a user inputto raise, but never lower, the second rate above the fixed low rate whenthe percentage of blood oxygen saturation is above, but never below, thepredetermined high percentage. In one variation, the oxygen deliveryprogram accepts a user input to raise, but never lower, the third ratewhen the percentage of blood oxygen saturation is above, but neverbelow, the predetermined high percentage.

In one example of the first alternate tenth expression of the embodimentof FIGS. 41-57, the second rate is substantially 2 liters per minute andthe third rate is 0 liters per minute for a predetermined highpercentage of substantially 96%, and the second rate is substantially 15liters per minute and the third rate is substantially 2 liters perminute for a predetermined low percentage of substantially 84%. In thisexample, the second rate is substantially 8 liters per minute and thethird rate is substantially 2 liters per minute when the percentage ofblood oxygen saturation is between substantially 88% and 96%, and thesecond rate is substantially 12 liters per minute and the third rate issubstantially 2 liters per minute when the percentage of blood oxygensaturation is between substantially 84% and 88%. Benefits and advantagesof this example include basing the oxygen delivery rate on the patient'soxygen saturation level, which provides a higher oxygen delivery ratefor a patient having low blood oxygen saturation while providing a loweroxygen delivery rate for a patient having high blood oxygen saturation,which conserves oxygen use. In this example, the flow rates may beassociated with a patient that is predominantly nasal breathing. If thepatient is predominantly oral breathing (indicated by the absence of anasal pressure signal) the flow rate may be the arithmetic means of theinhalation and exhalation rates for each blood oxygen segment.

A second alternate tenth expression of the embodiment of FIGS. 41-57 isfor a medical-effector-system procedure room unit 200′ (such as asedation-delivery-system procedure room unit 200) including aprocedure-room-unit host controller 204 which contains an oxygendelivery program. The program performs the steps of: controlling thedelivery of oxygen at a variable nasal-inhale oxygen-delivery flow rateto at least one respiratory-gas-delivery nasal prong 422′ and 422″ of acannula assembly 145 operatively connected to a patient, when thepatient is determined to be breathing through the nose and when thepatient is determined to be inhaling; and controlling the delivery ofoxygen at a nasal-exhale oxygen-delivery flow rate to the at-least-onerespiratory-gas-delivery nasal prong 422′ and 422″ when the patient isdetermined to be breathing through the nose and when the patient isdetermined to be exhaling. The patient has a variable percentage ofblood oxygen saturation, and the nasal-inhale oxygen-delivery flow rateis a variable rate, which depends on the percentage of blood oxygensaturation.

In one enablement of the second alternate tenth expression of theembodiment of FIGS. 41-57, the nasal-exhale oxygen-delivery flow rate isa variable rate, which depends on the percentage of blood oxygensaturation, and the nasal-inhale oxygen-delivery rate is greater thanthe nasal-exhale oxygen-delivery rate for the same percentage of bloodoxygen saturation.

An eleventh expression of the embodiment of FIGS. 41-57 is for medicaloxygen-delivery apparatus including an oxygen-delivery manifold 206. Theoxygen-delivery manifold 206 has an oxygen-delivery flow path and anoxygen-sampling flow path fluidly-connectable to the oxygen-deliveryflow path. The oxygen-delivery flow path includes a flow-path inletfluidly-connectable to a source of pressurized oxygen and a flow-pathoutlet fluidly-connectable to a cannula 351′ disposable on the face of apatient. The oxygen-sampling flow path includes an oxygen sensor 482,which detects hypoxic gas.

In one example of the eleventh expression of the embodiment of FIGS.41-57, an oxygen sample solenoid 481 fluidly connects theoxygen-sampling flow path to the oxygen-delivery flow path. In oneimplementation, a detection of hypoxic (low oxygen) gas by the oxygensensor 482 is used to issue a user alert to check the source of oxygen.In one employment, the oxygen-delivery manifold 206 is a subassembly ofa procedure room unit 200 of a sedation delivery system 100 (or othertype of medical-effector system 100′).

A twelfth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) including aprocedure-room-unit host controller 204 and a capnometer 140 and 202.The capnometer 140 and 202 has a capnometer gas input which receivesdirectly or indirectly respiratory gas obtained from a cannula 351′which is disposable on the face of a patient. The capnometer 140 and 202also has a capnometer signal output operatively connected to theprocedure-room-unit host controller 204. The procedure-room-unit hostcontroller 204 issues a user alert that the capnometer 140 and 202 isfluidly connected and/or not fluidly connected to the cannula 351′ basedat least in part on the capnometer signal output of the capnometer 140and 202.

In one example of the twelfth expression of the embodiment of FIGS.41-57, the capnometer input receives indirectly respiratory gas obtainedfrom the cannula 351′ through an intervening bedside monitoring unit300. The bedside monitoring unit 300 is attachable to the cannula 351′and is attached or attachable to a first end of an umbilical cable 160.The umbilical cable 160 has a second end attached or attachable to theprocedure room unit 200. At least one of the first and second ends isdetachable from the corresponding bedside monitoring unit 300 or theprocedure room unit 200. Typically, in this example, a detachedumbilical cable 160 would be responsible for most user alerts from theprocedure-room-unit host controller 204 that the capnometer 140 and 202is not fluidly connected to the cannula 35 1′. In one enablement, theprocedure-room-unit host controller 204 determines that the capnometer140 and 202 is fluidly connected to the cannula 351′ if the capnometeroutput indicates a valid respiratory rate of the patient based on a riseand fall of the capnometer output (i.e., a rise and fall of the carbondioxide level measured by the capnometer 140 and 202).

A thirteenth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) including asedation-delivery-system procedure-room-unit console 444 (or other typeof medical-effector-system procedure-room-unit console 444′) having aconsole fan 456 and a capnometer subassembly 140/202 and 141/142. Theconsole fan 456 moves air into, through, and out of theprocedure-room-unit console 444 (or 444′). The capnometer subassembly140/202 and 141/142 has a capnometer-subassembly gas inlet and acapnometer-subassembly gas outlet. The capnometer-subassembly gas outletis disposed to enable gas leaving the capnometer-subassembly gas outletto be entrained with air moved by the console fan 456.

In one example of the thirteenth expression of the embodiment of FIGS.41-57, the capnometer subassembly 140/202 and 141/142 has a capnometer140 and 202 and a capnometer pump 141 and 142 operatively connected tothe capnometer 140 and 202. In one construction of this example, gasflows from the capnometer-subassembly gas inlet to the capnometer to thecapnometer pump and to the capnometer-subassembly gas outlet. In anotherconstruction of this example, gas flows from the capnometer-subassemblygas inlet to the capnometer pump to the capnometer and to thecapnometer-subassembly gas outlet. One benefit of having gas from thecapnometer-subassembly gas outlet be fan-vented outside the console bythe console fan is that such outlet gas is less likely to contaminatethe capnometer calibration. In one arrangement, calibration gas andconsole fan air are drawn in the front of the console and exhausted fromthe back of the console.

In one extension of the thirteenth expression of the embodiment of FIGS.41-57, a sedation delivery system 100 (or other type of medical-effectorsystem 100′) includes the sedation-delivery-system procedure room unit200 (or other type of medical-effector-system procedure room unit 200′)described in the second previous paragraph, includes a bedsidemonitoring unit 300, and includes an umbilical cable 160. The umbilicalcable 160 has a first end attached or attachable to the bedsidemonitoring unit 300 and has a second end attached or attachable to theprocedure room unit 200. At least one of the first and second ends isdetachable from the corresponding bedside monitoring unit 300 or theprocedure room unit 200.

A fourteenth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200) including aprocedure-room-unit host controller 204, a capnometer 140 and 202, anoxygen manifold 206, and a low side pressure sensor 488. The capnometer140 and 202 has a capnometer gas input which receives directly orindirectly respiratory gas obtained from a cannula 351′ which isdisposable on the face of a patient and has a capnometer signal outputoperatively connected to the procedure-room-unit host controller 204.The oxygen manifold 206 has an oxygen-delivery flow path including inseries a flow-path inlet fluidly-connectable to a source of pressurizedoxygen, a flow restrictor 489 and 480, and a flow-path outletfluidly-connectable to the cannula 351′. The low side pressure sensor488 is in fluid communication with the flow-path outlet, is disposeddownstream of any oxygen-manifold flow restrictor 489 and 480, and has alow-side pressure signal output operatively connected to theprocedure-room-unit host controller 204. The procedure-room-unit hostcontroller 204 issues a user alert that the capnometer 140 and 202 isfluidly connected and/or not fluidly connected to the cannula 351′ basedat least in part on the capnometer signal output of the capnometer 140and 202 and the low-side pressure signal output of the low side pressuresensor 488.

In one example of the fourteenth expression of the embodiment of FIGS.41-57, the capnometer input receives indirectly respiratory gas obtainedfrom the cannula 351′ through an intervening bedside monitoring unit 300which is attachable to the cannula 351′ and attached or attachable to afirst end of an umbilical cable 160 having a second end attached orattachable to the procedure room unit 200. The flow-path outlet of theoxygen manifold 206 is indirectly fluidly-connected to the cannula 351′through the bedside monitoring unit 300 and the umbilical cable 160. Atleast one of the first and second ends is detachable from thecorresponding bedside monitoring unit 300 or the procedure room unit200.

A fifteenth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) including aprocedure-room-unit host controller 204, a capnometer 140 and 202 and acapnometer pump 141 and 142. The capnometer 140 and 202 has a capnometergas input which receives directly or indirectly respiratory gas obtainedfrom a cannula 351′ which is disposable on the face of a patient. Thecapnometer 140 and 202 also has a capnometer signal output operativelyconnected to the procedure-room-unit host controller 204. The capnometerpump 141 and 142 is operatively connected to the capnometer 140 and 202and is controlled by the procedure-room-unit host controller 204. Theprocedure-room-unit host controller 204 determines that the capnometer140 and 202 is fluidly connected and/or not fluidly connected to thecannula 351′ based at least in part on the capnometer signal output ofthe capnometer 140 and 202. The procedure-room-unit host controller 204shuts off, with or without a time delay, the capnometer pump 141 and 142when the capnometer 140 and 202 is not fluidly connected to the cannula351′. In one employment, shutting off the capnometer pump 141 and 142during times when the cannula 351′ is not in use avoids pollutants,impurities, etc. in the air from contaminating the capnometer 140 and202 during such times.

In one example of the fifteenth expression of the embodiment of FIGS.41-57, the capnometer input receives indirectly respiratory gas obtainedfrom the cannula 351′ through an intervening bedside monitoring unit300. The bedside monitoring unit 300 is attachable to the cannula 351′and is attached or attachable to a first end of an umbilical cable 160.The umbilical cable 160 has a second end attached or attachable to theprocedure room unit 200. At least one of the first and second ends isdetachable from the corresponding bedside monitoring unit 300 or theprocedure room unit 200.

A sixteenth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) including aprocedure-room-unit host controller 204, a capnometer 140 and 202, andan ambient-air pressure sensor 46. The capnometer 140 and 202 has acapnometer gas input which receives directly or indirectly respiratorygas obtained from a cannula 351′ which is disposable on the face of apatient. The capnometer 140 and 202 has a capnometer signal outputoperatively connected to the procedure-room-unit host controller 204.The ambient-air pressure sensor 46 has an ambient-air-pressure-sensorsignal output operatively connected to the procedure-room-unit hostcontroller 204. The procedure-room-unit host controller 204 determinesif the sedation-delivery-system procedure room unit 200 (or other typeof medical-effector-system procedure room unit 200′) has been moved to anew location having an altitude difference greater than a predeterminedaltitude difference using at least the ambient-air-pressure-sensorsignal output of the ambient-air pressure sensor 46. Theprocedure-room-unit host controller 204 issues a capnometer-calibrationuser alert when the sedation-delivery-system procedure room unit 200 (orother type of medical-effector-system procedure room unit 200′) has beenmoved to a new location having an altitude difference greater than thepredetermined altitude difference.

In one example of the sixteenth expression of the embodiment of FIGS.41-57, the capnometer input receives indirectly respiratory gas obtainedfrom the cannula 351′ through an intervening bedside monitoring unit300. The bedside monitoring unit 300 is attachable to the cannula 351′and is attached or attachable to a first end of an umbilical cable 160.The umbilical cable 160 has a second end attached or attachable to theprocedure room unit 200. At least one of the first and second ends isdetachable from the corresponding bedside monitoring unit 300 or theprocedure room unit 200.

A seventeenth expression of the embodiment of FIGS. 41-57 is for asedation-delivery-system procedure room unit 200 (or other type ofmedical-effector-system procedure room unit 200′) including aprocedure-room-unit host controller 204, a cannula 351′, and an oxygenmanifold 206. The cannula 351′ is disposable on the face of a patientand has a respiratory-gas-sample output operatively connectable to theprocedure-room-unit host controller 204. The oxygen manifold 206 has aflow-path outlet fluidly-connectable to the cannula 351′ and has avariable-size-orifice flow restrictor 480 operatively connected to, anddisposed upstream of, the flow-path outlet. The procedure-room-unit hostcontroller 204 determines when the patient is first breathing with adisposed cannula 351′ based at least on the respiratory-gas-sampleoutput of the cannula 351′ and opens the variable-size-orifice flowrestrictor 480 when the patient is first determined to be breathing witha disposed cannula 351′.

In one enablement of the seventeenth expression of the embodiment ofFIGS. 41-57, the respiratory-gas-sample output of the cannula 351′ isoperatively connected to the procedure-room-unit host controller 204 viaa pressure transducer (such as nasal pressure transducer 47) and/orthrough a capnometer 140 and 202. In the same or a different enablement,the variable-size-orifice flow restrictor 480 is a variable-size-orificesolenoid.

In one application of any of the above-described expressions of FIGS.41-57, including examples, etc. thereof, the procedure room unit 200 isdirectly attachable to a bedside monitoring unit 300. Other applicationsare left to the artisan.

Any one or more of the above-described expressions of the embodiment ofFIGS. 41-57, including examples, etc. thereof can be combined with anyother one or more of the above-described expressions of the embodimentof FIGS. 41-57, including examples, etc. thereof, as can be appreciatedby those skilled in the art.

In an alternate embodiment, as shown in FIG. 58, a procedure room unit50 includes an energy-delivery medical effector 52. An expression of theembodiment of FIG. 58 is for a medical effector system 54 including amicroprocessor-based bedside monitoring unit 56, a microprocessor-basedprocedure room unit 50, and an umbilical cable 58. The bedsidemonitoring unit 56 has a first series of connection points 60 forreceiving patient inputs from patient monitoring connections, has asecond series of connection points 62 for outputting patient outputsbased on the received inputs, and has a display screen 64 for displayingat least some of the patient outputs. The procedure room unit 50 has anenergy-delivery medical effector 52, and has a host controller 66 with amemory containing a patient-monitoring and medical-effector-schedulingprogram which is operatively connected to program inputs based at leastin part on at least some of the patient outputs and which controls,and/or advises a user to control, the energy-delivery medical effector52 based at least in part on the program inputs. The umbilical cable 58has a first end attached or attachable to the second series ofconnection points 62 of the bedside monitoring unit 56 and has a secondend attached or attachable to the procedure room unit 50. At least oneof the first and second ends is detachable from the correspondingbedside monitoring unit 56 or the procedure room unit 50. In oneexample, the energy-delivery medical effector 52 includes at least onemagnetic flux generator 68 adapted to deliver a time varying magneticfield to a patient to have a sedative effect on the patient. In onevariation, the at-least-one magnetic flux generator 68 includes a coil70.

FIG. 59 shows an embodiment of a medical effector subsystem 306. A firstexpression of the embodiment of FIG. 59 is for a medical effectorsubsystem 306 including a drug-delivery tube 308, a pressure sensor 324,and a memory 326. The drug-delivery tube 308 is adapted to containtherein a drug 328 having a variable commanded flow rate and isdisposable to deliver the drug to a patient 336. The pressure sensor 324has an output signal 338 and is adapted to sense internal pressure ofthe drug-delivery tube 308. The memory 326 contains an occlusion programwhich when running on a processor 344 is operatively connected to theoutput signal 338 of the pressure sensor 324. The occlusion program hasa variable pressure alarm setting and alerts a user of an occludeddrug-delivery tube 308 when the output signal 338 of the pressure sensor324 exceeds the variable pressure alarm setting. The occlusion programchanges the variable pressure alarm setting based at least in part, anddirectly or indirectly, on the variable commanded flow rate of the drug328.

The term “occluded” includes partially occluded and completely occluded.Causes of an occluded drug-delivery tube 308 include, withoutlimitation, a bent, twisted, squeezed, and/or blocked tube. In oneoperation of the first expression of the embodiment of FIG. 59, the drug328 is a pumped drug, which is pumped at the variable commanded flowrate. In this operation, when the drug-delivery tube 308 is occluded,the continued pumping of the drug 328 increases the internal pressure ofthe drug-delivery tube 308. It is noted that changing the variablepressure alarm setting based on commanded or actual pump speed ischanging the variable pressure alarm setting based indirectly on thevariable commanded flow rate of the drug, as is understood by theartisan. In one arrangement, since increasing the drug flow rateincreases the internal pressure of a non-occluded tube, the variablepressure alarm setting is set to always be higher (by a predeterminedamount in one example) than the non-occluded tube internal pressurecorresponding to the present commanded flow rate (or corresponding tothe present commanded or actual pump speed).

In one implementation of the first expression of the embodiment of FIG.59, the occlusion program sets the variable pressure alarm setting to afixed low setting when the variable commanded flow rate is below apredetermined value and sets the variable pressure alarm setting to afixed high setting when the variable commanded flow rate is at or abovethe predetermined value. In a different implementation, the occlusionprogram changes the variable pressure alarm setting whenever there is achange in the variable commanded flow rate. Other implementations areleft to the artisan.

In one employment of the first expression of the embodiment of FIG. 59,the drug-delivery tube 308 is an intravenous drug-delivery tube. In adifferent employment, not shown, the drug-delivery tube is a pneumatictube, wherein the drug is a gaseous drug. As previously mentioned,oxygen (i.e., air having an enriched oxygen content) is an example,without limitation, of a gaseous drug.

In one constuction of the first expression of the embodiment of FIG. 59,the pressure sensor 324 includes a pressure-sensitive input portion 346and the drug-delivery tube 308 has an imperforate outside surfaceportion 348. In this construction, the input portion 346 of the pressuresensor 324 is disposed in contact with the imperforate outside surfaceportion 348 of the drug-delivery tube 308. Other pressure sensor and/ordrug-delivery tube types and constructions are left to the artisanincluding, without limitation, a pressure sensor input which is in fluidcommunication with the drug inside the drug-delivery tube.

In one enablement of the first expression of the embodiment of FIG. 59,the memory 326 and the processor 344 are components of a host controllerof a procedure room unit (such as host controller 204 of thepreviously-described procedure room unit 200). In one variation, thememory 326 also contains a drug delivery algorithm, such as thepreviously mentioned Dosage Controller (DC) algorithm, which whenrunning on the processor 344 determines the variable commanded flowrate. In one modification, the variable commanded flow rate includes azero flow rate, a fixed maintenance flow rate, and a much larger fixedbolus flow rate. Other modifications, variations, and enablements areleft to the artisan.

In one application of the first expression of the embodiment of FIG. 59,the medical effector subsystem 306 also includes an infusion pump 350,which is adapted to receive the variable commanded flow rate. Theinfusion pump 350 has peristaltic pump fingers 372. The peristaltic pumpfingers 372 are disposed to interact with the drug-delivery tube 308 andare controllable to pump the drug 328 at the variable commanded flowrate.

A second expression of the embodiment of FIG. 59 is for a medicaleffector subsystem 306 including a drug-delivery tube 308, a pressuresensor 324, and a memory 326. The drug-delivery tube 308 is adapted tocontain therein a drug 328 having a variable commanded flow rate, isdisposable to deliver the drug 328 to a patient 336, and includes animperforate outside surface portion 348. The pressure sensor 324 has anoutput signal 338 and includes a pressure-sensitive input portion 346disposed in contact with the imperforate outside surface portion 348 ofthe drug-delivery tube 308. The memory 326 contains an occlusion programwhich when running on a processor 344 is operatively connected to theoutput signal 338 of the pressure sensor 324. The occlusion program hasa variable pressure alarm setting and alerts a user of an occludeddrug-delivery tube 308 when the output signal 338 of the pressure sensor324 exceeds the variable pressure alarm setting. The occlusion programchanges the variable pressure alarm setting based entirely, anddirectly, on the variable commanded flow rate of the drug 328.

A third expression of the embodiment of FIG. 59 is for a medicaleffector subsystem 306 including a drug-delivery tube 308, a pressuresensor 324, and an occlusion alarm unit 380. The drug-delivery tube 308is adapted to contain therein a drug 328 having a variable commandedflow rate and is disposable to deliver the drug 328 to a patient 336.The pressure sensor 324 has an output signal 338 and is adapted to senseinternal pressure of the drug-delivery tube 308. The occlusion alarmunit 380 is operatively connected to the output signal 338 of thepressure sensor 324 and has a variable pressure alarm setting to alert auser of an occluded drug-delivery tube 308 when the output signal 338 ofthe pressure sensor 324 exceeds the variable pressure alarm setting. Theocclusion alarm unit 380 changes the variable pressure alarm settingbased at least in part, and directly or indirectly, on the variablecommanded flow rate of the drug 328. In one example, the occlusion alarmunit 380 includes the previously-described memory 326 and processor 344of a procedure-room-unit host controller (such as previously-describedhost controller 204) and alerts the user through a popup window on amonitor (such as procedure-room-unit monitor 441, as shown in FIG. 48).In another example, not shown, the occlusion alarm unit does not involvea processor of a procedure-room-unit host controller.

A fourth expression of the embodiment of FIG. 59 is for a drug-deliveryinfusion pump subassembly 382 including a drug-delivery tube 308,peristaltic pump fingers 372, a pressure sensor 324, and an occlusionalarm unit 380. The drug-delivery tube 308 is adapted to contain thereina drug 328 and is disposable to deliver the drug 328 to a patient 336.The peristaltic pump fingers 372 are disposed to interact with thedrug-delivery tube 308 and are controllable to pump the drug 328 at acommanded flow rate. The pressure sensor 324 has an output signal 338and is adapted to sense internal pressure of the drug-delivery tube 308downstream of the peristaltic pump fingers 372. The occlusion alarm unit380 is operatively connected to the output signal 338 of the pressuresensor 324 and has a variable pressure alarm setting to alert a user ofan occluded drug-delivery tube 308 when the output signal 338 of thepressure sensor 324 exceeds the variable pressure alarm setting. Theocclusion alarm unit 380 changes the variable pressure alarm settingbased entirely, and directly, on the variable commanded flow rate of thedrug.

In one implementation of the fourth expression of the embodiment of FIG.59, the drug-delivery tube 308, the peristaltic pump fingers 372, thepressure sensor 324, and the occlusion alarm unit 380 are components ofa procedure room unit of a medical effector system (such as theprocedure room unit 200 of the previously-described medical effectorsystem 100′). In one example of the fourth expression of the embodimentof FIG. 59, the occlusion alarm unit 380 includes thepreviously-described memory 326 and processor 344 and alerts the userthrough a popup window and/or a flashing visual alarm displayed on amonitor (such as procedure-room-unit monitor 441, as shown in FIG. 48)and/or through a noise alarm. In another example, not shown, theocclusion alarm unit does not involve a processor of aprocedure-room-unit host controller and operates independently of, andin the absence of, the previously-described procedure room unit 200.

It is noted that implementations, employments, constructions, etc. ofthe first expression of the embodiment of FIG. 59 are equally applicableto any one or more or all of the second through fourth expressions ofthe embodiment of FIG. 59. In one example of one or more or all of theexpressions of the embodiment of FIG. 59, the patient 336 receiving thedrug 328 is better controlled by having the occlusion pressure alarmsetting change based on the variable commanded flow rate of the drug328. Better control is achieved because the response time to anocclusion, and any bolus buildup, will be minimized compared to using aconventional fixed very-high occlusion pressure alarm setting for allcommanded flow rates of the drug. It is also noted that suchconventional alarm setting had to be higher than that corresponding tothe highest actual flow rate of the drug (which is least used) becausethe internal pressure of a non-occluded drug-delivery tube increaseswith increasing actual flow rate of the drug, as can be appreciated bythose skilled in the art. It is further noted that with such highconventional fixed alarm setting it would take much longer for a lowcommanded flow rate to generate enough internal pressure in an occludeddrug-delivery tube to cause an occlusion alarm, and once such highinternal pressure were released, a large bolus of drug would be sent tothe patient as well.

The following paragraphs present a detailed description of oneparticular enablement of the embodiment of FIGS. 41-57. It is noted thatany feature(s) of this particular enablement can be added to any of thepreviously-described expressions (including examples, etc. thereof) ofthe embodiment of FIGS. 41-57. In this enablement, the PRU 200 is themain interface between the SDS 100 and the care team member responsiblefor administering drug(s). The PRU 200 is designed for use in theprocedure room. The PRU 200 connects to the BMU 300 by means of anUmbilical Cable 160. The PRU 200 accepts input from all physiologicsignals provided by means of the BMU 300 as well as from the NasalCapnometer Module 140 and Oral Capnometer Module 202 located within thePRU 200. The PRU 200 accepts user-input parameters such as patient data,drug dose rate targets, and alarm trigger settings. The PRU 200processes these physiologic signals and user-input parameters; displaysthe physiologic signals, derivations of these signals, and related alarmstatus for user observation; and performs drug delivery and oxygenmetering in accordance with algorithms driven by these signals.

Dosage Controller (DC) is a drug delivery algorithm utilized by the PRU200 and is an enhancement of Dose Rate Control (DRC). The enhancementincludes the algorithm's ability to calculate the appropriate loadingdose, which is based upon drug labeling guidelines. For a givenmaintenance rate, the DC calculates an appropriate loading dose thatpermits the rapid achievement of the sedation effect at the initiationof the medical procedure.

The PRU 200 incorporates interactive software called the monitoringshell, which monitors and displays the patient condition and makesdecisions about the patient status and resultant drug delivery schedule.The monitoring shell utilizes algorithms to quantify patient status,control drug delivery rate and oxygen delivery rate, and presents alarmsto the user. The monitoring shell utilizes a broad array of inputparameters including DC data, patient physiologic monitoring data,patient physical data, and alarm trigger settings. The monitoring shellreduces or stops drug delivery, along with alerting the user, if itdetects certain undesired patient sedation condition(s). It will resumedrug delivery if such undesired patient sedation conditions aresubsequently corrected. The drug dose rate is based on user-inputparameters, such as the recommended dose rate and patient weight, andsoftware-based decisions in accordance with applied pharmacologicprinciples. The oxygen delivery rate is based on user-input parametersalong with patient physiologic monitoring data such as oxygen saturationlevel.

The PRU 200 incorporates an intuitive display screen presentation thatis called the PRU Graphical User Interface (PRU GUI) 210. The PRU GUI210 displays the status of the patient in terms of physiologicparameters and alarms/alerts; it also presents the functionality statusof internal sensors and operational data. The PRU GUI 210 also providesa simple intuitive means for the user to input parameters such aspatient data, drug dose rate, and alarm trigger levels. One feature ofthe PRU GUI 210 is the PRU intelligent alarm box 249 which allows theuser to rapidly ascertain the patient's general condition by means ofthe colors Green, Yellow, and Red. The PRU intelligent alarm box 249utilizes algorithms to calculate and present a robust broadly definedstatus of the patient.

Besides the DC, the monitoring shell, and PRU GUI 210, the PRU 200incorporates other software-driven operations. These operations includemonitoring functions and convenience functions. The conveniencefunctions include an auto-prime that provides automatic infusion line224 priming when the cassette 251 and drug vial 250 have been installedinto PRU 200. The monitoring functions include an infusion line priminginterlock that allows infusion line 224 priming when the T-site luer 269is attached to the T-site base 271 of the cassette 251. The monitoringfunctions also include oxygen delivery when connected to the patient anddrug delivery when a cassette 251 is not recognized by the PRU aspreviously utilized in the PRU.

The PRU 200 includes an uninterruptible power supply (UPS) 214, a PRUconsole 444, and a PRU monitor 441. These items are stacked in the orderdescribed and typically reside upon an SDS cart 101 or upon the user'sown platform.

The UPS 214 converts AC wall-outlet power to a low voltage power thatprovides all of the electrical energy utilized by the PRU console 444.The primary portion of the UPS 214 power that is fed to the PRU console444 is utilized by the PRU console 444, while the remainder of the poweris fed, via the PRU console 444, to the PRU monitor 441 and to the BMU300. The UPS 214 also has a rechargeable battery backup subsystem, whichis utilized, as a temporary power source that is automatically invokedby the UPS 214 when there is an outage of AC wall-outlet power otherwiseprovided via an AC power cord. The UPS 214 also provides the PRU console444 with an earth connection for electrical grounding. There iscommunications means between the UPS 214 and the PRU console 444 thatconveys information regarding power status and battery status relatedfeatures. The power, communications, and the earth connection areconveyed to the PRU console 444 by means of a low voltage power cord,called the UPS output cable 490, that is integral to the UPS 214 wherebythe UPS output cable connector 491, located on the end of this UPSoutput cable 490, is plugged into the PRU console 444.

The UPS 214 includes an external AC power cord, universal AC/DC powermodule 501, UPS power management circuit board 502, and UPS rechargeablebattery pack 503. The UPS 214 has an externally located UPS on/offswitch 504, an UPS power status indicator 505 to display power status,and an UPS battery status indicator 506 to indicate battery chargestatus.

UPS 214 further includes cooling fans 507 which are located to the rearof UPS chassis 508. A decorative front bezel 509 attaches to UPS chassis508 and UPS top cover 473. UPS top E-PAC™ 474 and bottom E-PAC™ 475 arefoam structures that function to secure all UPS internal components.

The UPS 214 incorporates electrical circuitry that permits the UPSoutput cable connector 491 to be detached from the PRU console 444 whilepower is flowing while helping to prevent electrical contact sparking orundue electrical stress to the connector. The UPS output cable connector491 also incorporates means to assure that the earth connection contactsare the first contacts to be made during the UPS-to-PRU connection andthese are the last contacts to open during disconnection.

The PRU monitor 441 provides the user with an interface to the PRU 200that combines a color PRU monitor display 442, PRU monitor touchscreen443 user interface, and PRU monitor speakers 458 and 459. The PRUmonitor 441 is seated upon the top of the PRU console 444. The PRUmonitor 441 is provided power and earth connection by the PRU console444. Video and audio signals are also provided by the PRU console 444.The PRU monitor 441 sends PRU monitor touchscreen 443 signals to the PRUconsole 444.

The PRU monitor 441 is electrically attached to the PRU console 444 bymeans of a PRU monitor cable that is plugged into the rear of the PRUconsole 444. This cable provides the conveyance means for power, earthconnection, video, audio, and PRU monitor touchscreen 443 signals. ThePRU monitor cable connector 463 also incorporates means to assure thatthe earth connection contacts are the first contacts to be made duringconnection and the last contacts to open during disconnection.

The PRU console 444 is the central computational and process controlresource of the SDS 100. The PRU console 444 also contains specificfunctions including the drug infusion; patient CO2 gas analysis by meansof capnometry; supplemental oxygen flow control; barcode reading ofcassette 251, oral/nasal cannula 145, and drug vial 250 barcode label(s)that is located upon the item or its packaging; patient data hardcopyprinting; communications within the SDS 100; communications to externalresources; and power control/management.

The PRU console 444 includes a PRU power management board 453, PRUprocessor board 452, system I/O board 451, barcode reader moduleassembly 455, PRU printer 454, IV (intravenous) pump module 220, oxygenmanifold 206, control buttons and lighted indicators, external userconnectors, and PRU console fan 456. All of these items are enclosedwithin a single cabinet shroud. The PRU processor board 452 and thesystem I/O board 451, which are linked together with a flexible circuitwire harness, are together referred to as the PRU host controller 204.

The PRU power management board 453 accepts the UPS 214 power enteringthe PRU console 444 and converts it to several lower voltage regulatedoutputs for use by the PRU 200 and the BMU 300. In one example theseregulated outputs include 5V (volts), 12V, and 15V.

The PRU processor board 452 provides the primary computation resourcefor the SDS 100 and is one of the primary resources for signalinput/output. The majority of the SDS 100 software, including the DC andthe monitoring shell, reside in non-volatile memory located on the PRUprocessor board 452. The PRU processor board 452 includes a centralprocessing unit (CPU), RAM Memory, disc-on-chip memory, and anassortment of digital I/O, analog I/O, video, and audio circuitry.

A flexible circuit wire harness provides interconnection between aboutone hundred signal input/output lines of the PRU processor board 452 andthe system I/O board 451. It includes a multi-dimensional flex printcircuit board incorporating about ten connectors.

The system I/O board 451 is a multi-functional circuit board thatintegrates and processes signals from most circuits located within thePRU console 444 including the PRU processor board 452, IV pump module220, PRU printer 454, barcode reader module 455, and a diversity ofoperational circuits on the system I/O board 451 itself. It alsoprocesses signals involving other sources outside the PRU console 444such as signals from the UPS 214, BMU 300, and PRU Monitor 441.

The system I/O board 451 has circuitry resident upon the board itself.The system I/O board 451 also contains modules that are mounted upon theboard such as the nasal capnometer module 140 and oral capnometer module202 and a flash memory module 466.

Numerous system I/O board 451 functional circuits are described in thefollowing paragraphs.

The flash memory module 466 is detachable, user accessible, and providesfor upgrades to the SDS 100 internal memory in order to revise softwarefor system operation.

There is a nasal capnometer module 140 and an oral capnometer module202, which are mounted to and are a part of the system I/O board 451.The nasal capnometer module 140 monitors the patient's combined nasalexhale. The oral capnometer module 202 monitors the patient's oralexhale. Each capnometer module 140 and 202 includes a suction pumpcontrol circuit that controls a suction pump, located independent fromthe system I/O board 45 1I, that draws in the patient sample in acontrolled sample flow rate. Each capnometer module 140 and 202 includessample line pressure sensors that monitor sample line pressure to detectsample line occlusions and to compensate CO2 measurements in accordancewith sample line barometric pressure. Both capnometer modules 140 and202 have their own software, which provides for automatic calibrationsas needed, communications with the PRU host controller 204, and otherfunctions. There are a first and second capnometer I/O circuit thatreside on the system I/O board 451 and serve as the interface betweenthe respective capnometer module 140 and 202 and the PRU processor board452. One function of this circuitry is to control power to thecapnometer module 140 and 202 electronics and the motors of capnometerpumps 141 and 142 in accordance with PRU processor board 452 commands.

The fast switch circuit resides on the system I/O board 451 and providesfor control of power that is applied to the PRU umbilical cableelectrical receptacle 461. This circuit helps prevent sparking due toconnect/disconnect of otherwise electrified receptacles and disconnectspower to umbilical cable 160 connector pins that may be exposed duringdisconnection.

The PRU state circuit 510 works in conjunction with a similar statecircuit, the BMU state circuit 600 in the BMU 300, whereby both statecircuits 510 and 600 interact via the umbilical cable 160 communicationmeans. The PRU state circuit 510 in the PRU console 444 provides themeans for the PRU console 444 to be aware of whether the umbilical cable160 is plugged into the BMU 300 and whether the BMU 300 is energized oroff. This state status information is utilized by the PRU console 444.For example, if the PRU 200 is off and if the BMU 300 is on, then theBMU 300 is attached via the umbilical cable 160 to the PRU 200 and thePRU 200 will automatically turn itself on. Another use for the statestatus is to prevent umbilical cable 160 communications alarms relatedto intentional disconnection of the umbilical cable 160. Yet anotherrole of the state status in the PRU 200 is to help control when power isapplied to the PRU umbilical cable electrical receptacle 461 in order tohelp avoid application of power to the exposed pins of an unpluggedumbilical cable 160.

An IV pump power control circuit controls power to the IV pump module220 in accordance with various commands from the PRU processor board 452and from interlocks such as the controller-monitoring module 467circuit. Also included in this circuit is a stop drug button 497 whichforces shutdown of power to the IV pump module 220 and also communicatesthe status of this button to the PRU processor board 452. Also includedin this circuit is a pump door button 496, which communicates the statusof this button to the PRU processor board 452 and also assists with thecontrol of the door latch solenoid 222 that unlocks the pump door 201.Yet another function of this circuit is to convey the signal status ofthe IV pump motor encoder to the PRU processor board 452.

A PRU power button circuit monitors the power button 495, whichcommunicates the status of this button to the PRU processor board 452.The PRU power button circuit also includes an LED indicator drivercircuitry that provides a ramping current to the LED indicator of thePRU power status indicator 498 while in the standby mode which producesa variable luminous indication during standby. When in the On mode, thiscircuit drives the LED indicator of the PRU power status indicator 498with a continuous current.

A PRU printer circuit provides electrically isolated controlled powerfor the PRU printer 454 and also provides electrically isolatedcommunications between the PRU processor board 452 and the PRU printer454. A barcode reader circuit provides controlled power for the barcodereader module 455 and also provides a communications interface for thebarcode reader module 455 to the PRU processor board 452. A PRU fancontrol circuit controls power to the PRU console fan 456. This circuitis able to detect a slow running or stalled PRU console fan 456 and thenissue an alert to the PRU processor board 452.

A PRU temperature sensor circuit incorporates a thermal sensor andsignal processing that monitors the internal temperature of the PRUconsole 444 and presents that temperature data to the PRU processorboard 452. This thermal sensor, along with associated support circuitry,is located on the system I/O board 451 where it can effectively monitorthe thermal status inside the PRU Console 444.

The controller-monitoring module 467 is a monitor circuit that monitorsthe viability of the PRU host controller 204 and associated softwareprograms it is running. If the controller-monitoring module 467 detectsundesired PRU host controller 204 function (including in terms of toofrequent or infrequent processor activity), the controller-monitoringmodule 467 will notify the PRU processor board of this condition and thecontroller-monitoring module 467 will take direct action to disable theIV pump module 220 and shut down most functions within a short period oftime. In the event of a controller-monitoring module 467 detectableevent, the controller-monitoring module 467 will also temporarily sounda buzzer that is located on the PRU system I/O board 451, as a means tonotify the user of the undesired condition.

A PRU monitor control circuit controls power to the PRU monitor 441. Itis controlled by the PRU processor board 452 and the circuit includes acurrent limiting function. A PRU audio amplifier circuit includes twoaudio amplifier circuits that accept low level audio from the PRUprocessor board 452 and amplify these signals. These amplified signalsare utilized to drive the two PRU monitor speakers 458 and 459 in thePRU monitor 441. The monitor control circuit includes conveyance of aPRU monitor speaker interlock signal to the PRU processor board 452which helps assure that the SDS 100 only operates if the PRU monitorspeakers 458 and 459 are connected to the PRU console 444.

A modem circuit provides a means for the SDS 100 to communicate withnon-SDS devices via a telephone line. This circuit implements isolatedcircuitry. An Ethernet circuit provides a means for the SDS 100 tocommunicate with non-SDS devices via an Ethernet line. This circuit alsoimplements isolated circuitry.

PRU UPS communications interface is a circuit that provides theinterface between the UPS communications lines and the PRU processorboard 452.

A supplemental oxygen control circuit provides the basic signalprocessing interface between the PRU processor board 452 andsupplemental oxygen related sensors. The sensors include the oxygensensor 482, the high side oxygen pressure sensor, the low side oxygenpressure sensor, and the differential pressure sensor. One of thesesensors, the differential pressure sensor, is physically located on thesystem I/O board 451 in the vicinity of this circuit, while the otherlisted sensors are located on the oxygen manifold 206. The supplementaloxygen control circuit also provides power signals that drive thevariable-size-orifice (VSO) flow restrictor 480 (such as a VSOsolenoid), which regulates supplemental oxygen flow. Included featuresare electrical control of the VSO flow restrictor 480 and the signalprocessing interface between the PRU processor board 452 and the VSOflow restrictor 480. Yet another role of the supplemental oxygen controlcircuit is to control the oxygen sampling solenoid in accordance withcommands received from the PRU processor board 452.

The last-to-be-discussed system I/O board 451 functional circuit is thevoltage monitoring circuit. The voltage monitoring circuit provides aninterface between the PRU processor board 452 and the various powersupply voltages resident on the system I/O board 451 in order to monitorthose voltages and determine if they are in desired ranges.

There is a nasal capnometer pump 141, located within the PRU console444, which is plumbed, but not physically affixed, to the nasalcapnometry module 140. There is an oral capnometer pump 142, locatedwithin the PRU console 444 which is plumbed, but not physically affixed,to the oral capnometry module 202.

The barcode reader assembly 455 incorporates a self-contained barcodereader module 464 that is mounted on a metal frame that includes amirror. The metal frame is mounted inside the housing of PRU console 444in an orientation that allows the projection of the barcode laser beamthrough an open window of the housing of the PRU console 444 to shineupon an area external to the PRU console 444. The user places thebarcode of the packaging containing the oral/nasal cannula 145 orcassette 251 or drug vial 250 within reading range of the active barcodereader module 464 laser beam. The barcode reader module 464 then readsthe barcode.

The PRU printer 454 includes a thermal print head, a paper feedmechanism, a printer driver board, and a PRU printer door 460. Thisassembly is mounted to the housing of the PRU console 444 utilizingelectrically isolated means that helps provide for an electricallyisolated access to the printer paper roll.

The IV pump module 220 provides the drug pumping function of the PRUconsole 444. The IV pump module 220 accepts the disposable cassette 251.The IV pump module 220 propels metered drug(s) through the cassette 251via peristaltic massage of the flexible tube 277. The IV pump module 220detects the presence of the T-site commercial luer 269 placement intothe respective receptacle of cassette 251 and also detects drug vial 250seating upon the respective receptacle of the cassette 251. The IV pumpmodule 220 incorporates several features such as detection ofair-in-line and occlusion of the downstream fluid path. Another functionof the IV pump module 220 is the pump door 201 and the controlledopening of the pump door 201.

The IV pump module 220 includes an IV pump housing 239 that has attachedto it the pump door 201, the pump door latch 205 and the pump doorlifting mechanism 207, IV pump assembly 232, IV pump control board 233,an optical sensor board, and air-in-line sensor 225. The IV pumpassembly 232 includes an IV pump motor, a pump finger mechanism, an IVpump motor encoder, downstream IV pressure sensor 223, and an IV pumpsensor board. The optical sensor board 227 has the T-site sensor 226 andthe vial sensor 228. These two sensors protrude through the IV pumphousing 239 in the vicinity of the pump cassette deck 221 where theyinteract with the associated mechanisms of the seated disposablecassette 251. The optical sensor board also has a door latch solenoid222 that, when activated, presses upon the pump door latch 205 torelease the pump door 201, whereby the pump door 210 is lifted by pumpdoor lifting mechanism 207 and proceeds to the open position to exposethe cassette deck 221 and permit the user access for installation orremoval of the cassette 251.

The oxygen manifold 206 is the primary component of the supplementaloxygen delivery subsystem of the PRU console 444. The oxygen manifold206 provides a path for oxygen flow, oxygen flow control, oxygen purityevaluation, and oxygen overpressure relief. It is mounted at the rearsection of the PRU console 444.

The oxygen manifold 206 includes a manifold that is equipped with thefollowing items that are encountered by incoming oxygen gas in the orderlisted: externally located oxygen input coupler 484, high side pressurerelief valve 485 and associated exhaust port, high side pressure sensor487, oxygen diverter 492, fixed restrictor 489, VSO flow restrictor 480,low side pressure sensor 488, low side pressure relief valve 486, andoxygen main output outlet. Ancillary gas paths include an oxygen samplesolenoid 481, oxygen sensor 482, and oxygen sensor exhaust port 483.There are also outlets for plumbing gas pressure from each side of thefixed restrictor 489 to the differential pressure sensor 479 which islocated on the system 1/O board 451. The oxygen manifold 206 has anoxygen input coupler 484 that protrudes from the rear of the PRU console444 for user connection to an external supply of supplemental oxygen.

The oxygen manifold 206 has a flow path that intercepts an oxygensample. The oxygen sample is gated by an oxygen sample solenoid 481 totemporarily allow flow of supplemental oxygen past the attached oxygensensor 482. The oxygen manifold 206 has an oxygen sensor exhaust port483 that permits the sampled gas to be expelled from the oxygen manifold206.

The oxygen manifold 206 utilizes a high side pressure relief valve 485that protects the oxygen high pressure path from excessive high supplypressure by relieving that pressure via the exhaust port of the highside pressure relief valve 485. The oxygen manifold 206 utilizes a lowside pressure relief valve 486 that protects the oxygen low pressurepath from excessive output pressure by relieving any excessive pressurevia the exhaust port of the low side pressure relief valve 486.

The oxygen diverter 492 is a manually operated valve and is operated viaan externally accessible oxygen diverter knob 493. This oxygen diverter492 can be set to the normal position whereby the supplemental oxygenflow is only directed through the regulated flow path of the SDS 100system. The oxygen diverter 492 can alternately be set to theSDS-system-bypass position, whereby the supplemental oxygen flow nolonger flows through the regulated flow path of the SDS 100 system.Instead, it flows exclusively directly to an externally accessiblebarbed oxygen outlet 494 that provides the user with a convenient meansto connect a user-provided SDS-system-bypass oxygen delivery device.

The PRU console 444 provides a direct means for user input via the PRUpower button 495, the stop drug button 497, and the pump door button496. The PRU power button 495 allows the PRU 200 to be placed intostandby or ready mode. The stop drug button 497 allows the user to haltdrug(s) delivery by cutting off power to the IV pump module 220. Thepump door button 496 allows the user to open the pump door 201 whenthere is no cassette 251 installed in the IV pump module 220 or when thecassette 251 is present and the T-Site commercial luer 269 is installedinto the cassette 251.

The PRU console 444 provides the user with status indications by meansof two illuminated indicators. One of these indicators is the PRU powerstatus indicator 498, which is integral to the PRU power button 495.This indicator has a periodic fluctuating brilliance when in standbymode and a continuous brilliance in the ready mode. The other indicatoris the pump door locked indicator 499 which is integral to the pump doorbutton 496, which is lit when the pump door 201 is locked, and which isnot lit when the pump door 201 is not locked.

The PRU console 444 has several externally user accessible connectors.The PRU umbilical cable electrical receptacle 461, located on the frontpanel of the PRU console 444, is a connector for providing convenientelectrical connections to umbilical cable 160. It utilizes various pinheights to provide hot switching without degradation of pins. The PRUumbilical cable pneumatic receptacle 462, located on the front panel ofthe PRU console 444, is a connector for providing convenientsimultaneous multiple pneumatic connections to umbilical cable 160including pneumatic paths for oxygen delivery and patient exhalesamples. The modem connector 470, located on the rear panel of the PRUconsole 444, is a type RJ11 connector for providing user connection toan external telephone line. The Ethernet connector 471, located on therear panel of the PRU console 444, is a type RJ45 connector forproviding user connection to an external Ethernet line. The PRU powerconnector 465, located on the rear panel of the PRU console 444, is aconnector for providing user connection of PRU console 444 to UPS outputcable connector 491.

The PRU console 444 has a fan referred to as the PRU console fan 456.The PRU console fan 456 provides thermal cooling of the componentslocated inside the PRU console 444. The PRU console fan 456 alsoprovides for robust ventilation of the PRU console 444 as a means todilute any potentially present supplemental oxygen entering the PRUconsole 444 thereby helping keep the oxygen concentration within adesired range.

The internal components of PRU 200 are sandwiched between top PRU foamsupport 447 and bottom PRU foam support 448. In one example, PRU foamsupports 447 and 448 are constructed of rigid foam well known in theelectronics industry as an E-PAC™ chassis. Strategically locatedrecesses and cavities in the E-PAC™ chassis efficiently capture andsecurely hold pc boards, pumps, LCD, speaker and other components. Theouter housing of PRU 200 is constructed of rigid molded thermoplastic(e.g. ABS) and includes top chassis 445, top bezel 446 and front bezel450. Bottom chassis 449 is constructed of sheet metal and forms part ofthe outer housing of PRU 200. The housing components are held togetherwith molded-in snap features and screws. Top chassis 445 is designed tobe readily removable for access to the PRU 200.

PRU/BMU Interface

A fourth aspect of the invention is directed to a procedure room unit(PRU) 200 and bedside monitoring unit (BMU) 300 interface of a sedationdelivery system 100 (or other type of medical-effector system 100′), anembodiment of which is shown in FIGS. 41-57 and 60-62. An expression ofthe embodiment of FIGS. 41-57 and 60-62 is for a sedation deliverysystem 100 (or other type of medical-effector system 100′) including amicroprocessor-based bedside monitoring unit 300 (an embodiment of whichis shown in FIGS. 41 and 60-62), a microprocessor-based procedure roomunit 200 (an embodiment of which is shown in FIGS. 41-57), and anumbilical cable 160 (an embodiment of which is shown in FIGS. 41, 42, 60and 61). The bedside monitoring unit 300 has a bedside-monitoring-unithost controller 301, has a first series of connection points forreceiving patient inputs from patient monitoring connections, has asecond series of connection points for outputting patient outputs basedon the received inputs, and has a display screen for displaying at leastsome of the patient outputs. The procedure room unit 200 has adrug-delivery flow control assembly 220′ (or other type of medicaleffector 220″) and has a procedure-room-unit host controller 204. Theprocedure-room-unit host controller 204 has a memory containing apatient-monitoring and drug-delivery-scheduling program (or otherpatient-monitoring and medical-effector-scheduling program). The programis operatively connected to program inputs based at least in part on atleast some of the patient outputs and controls, and/or advises a user tocontrol, the drug-delivery flow control assembly 220′ (or other medicaleffector 220″) based at least in part on the program inputs. Theumbilical cable 160 has a first end attached or attachable to the secondseries of connection points of the bedside monitoring unit 300 and has asecond end attached or attachable to the procedure room unit 200. Atleast one of the first and second ends is detachable from thecorresponding bedside monitoring unit 300 or the procedure room unit200. The procedure-room-unit host controller 204 and thebedside-monitoring-unit host controller 301 are operatively connectedtogether when the umbilical cable 160 is attached to the procedure roomunit 200 and the bedside monitoring unit 300.

In one arrangement of the expression of the embodiment of FIGS. 41-57and 60-62, the drug-delivery flow control assembly 220′ includes adrug-delivery infusion pump assembly 220 such as a peristaltic pumpassembly. In one variation of this arrangement, the drug(s) is deliveredto the patient through an IV. In another arrangement, not shown, thedrug-delivery flow control assembly includes a gaseous-drug gas flowcontroller. In one variation of this arrangement, the gaseous drug(s) isoxygen and/or a non-oxygen gas and is delivered to the patient through acannula assembly.

In one example of the expression of the embodiment of FIGS. 41-57 and60-62, the procedure room unit 200 has an individual procedure-room-unit(PRU) identifier and the bedside monitoring unit 300 has an individualbedside-monitoring-unit (BMU) identifier. The procedure-room-unit hostcontroller 204 of the procedure-room unit 200 compiles an electronichistory of the bedside monitoring unit 300 when attached to theprocedure room unit 200 based on the individual BMU identifier. In onevariation, the identifiers reside in the host controllers of the PRU andBMU, and the electronic history is automatically compiled when the BMUis attached to the PRU. In one extension, the sedation delivery system100 also includes a single-patient-use drug-delivery cassette assembly251 and a single-patient-use cannula assembly 145 and asingle-patient-use drug vial 250. The drug-delivery cassette assembly251 has an individual cassette identifier and is operatively connectableto the drug-delivery flow control assembly 220′ of the procedure roomunit 200. The cannula assembly 145 has an individual cannula identifierand is attachable to the bedside monitoring unit 300. The drug vial hasan individual vial identifier and is operatively connectable to thedrug-delivery cassette assembly 251. The procedure-room-unit hostcontroller 204 of the procedure-room unit 200 compiles an electronichistory of the drug-delivery cassette assembly 251 and the cannulaassembly 145 and drug vial 250 based on the individual cassette andcannula and vial identifiers (the SPU identifiers).

In a further expression of the embodiment of FIGS. 41-57 and 60-62, theprocedure room unit 200 downloads has an individual procedure-room-unit(PRU) identifier and the bedside monitoring unit 300 has an individualbedside-monitoring-unit (BMU) identifier. The procedure-room-unit hostcontroller 204 of the procedure-room unit 200 compiles an electronichistory of the bedside monitoring unit 300 when attached to theprocedure room unit 200 based on the individual BMU identifier.

In a further expression of the embodiment of FIGS. 1-57 and 60-62, thedrug cassette assembly 251 individual cassette identifier is a uniquebarcode of a sterile package containing the drug cassette assembly 251and/or a barcode on the drug cassette assembly 251. The cannula assembly145 individual cannula assembly identifier is a unique barcode of asterile package containing the cannula assembly 145 and/or a barcode onthe cannula assembly 145. The drug vial 250 individual vial identifieris a unique barcode of a sterile package containing the drug vial 250and/or a barcode on the drug vial 250. The unique identifiers are readat PRU 200 using barcode reader 455.

In one enablement of the expression of the embodiment of FIGS. 41-57 and60-62, when the bedside monitoring unit 300 is attached to the procedureroom unit 200, the electronic history of the cassette, cannula and vialidentifiers is passed on to BMU 300. The BMU 300 updates its electronichistory of SPU identifiers so previously used SPUs cannot be used againwith that particular BMU. In a further enablement, the BMU 300 alsocopies its history of SPU identifiers to PRU 200. This is particularlyuseful in surgical procedure suites that have multiple BMUs and fewerPRUs. The cross copy of SPU identifiers between BMUs and PRUs furtherprevents multiple use of SPUs on different PRUs within a surgical suite.

In one enablement of the expression of the embodiment of FIGS. 41-57 and60-62, when the bedside monitoring unit 300 is attached to the procedureroom unit 200, the bedside-monitoring-unit host controller 301 of aturned-on bedside monitoring unit 300 turns on a turned-off procedureroom unit 200. In the same or a different enablement, when the bedsidemonitoring unit 300 is attached to the procedure room unit 200, theprocedure-room-unit host controller 204 of a turned-on procedure roomunit 200 turns on a turned-off bedside monitoring unit 300. In onevariation, when a PRU 200 or a BMU 300 is turned on, its host controller204 and 301 boots up.

In one illustration of the expression of the embodiment of FIGS. 41-57and 60-62, the bedside monitoring unit 300 displays patient monitoringwhile not attached to the procedure room unit 200 and displays patientmonitoring while attached to the procedure room unit 200 when theprocedure-room-unit host controller 204 detects certain faults in theprocedure room unit 200. In the same or a different illustration, theprocedure-room-unit host controller 204 shuts off the drug-deliveryinfusion pump assembly 220 when certain faults are detected in anattached bedside monitoring unit 300 and/or in the procedure room unit200.

In one implementation of the expression of the embodiment of FIGS. 41-57and 60-62, the umbilical cable 160 includes a power feed line, and theprocedure-room-unit host controller 204 shuts off power to the powerfeed line of the umbilical cable 160 when the umbilical cable 160 isdisconnected from the bedside monitoring unit 300 and/or the umbilicalcable 160 is disconnected from the procedure room unit 200. In onevariation, the bedside monitoring unit 300 includes abedside-monitoring-unit battery 303, and power from the procedure roomunit 200 charges the bedside-monitoring-unit battery 303 via the powerfeed line of the umbilical cable 160.

Bedside Monitoring Unit

A fifth aspect of the invention is directed to, or a component of, orcan be used by, a bedside monitoring unit (BMU) 300, an embodiment ofwhich is shown in FIGS. 6, 41 and 60-62. A first expression of theembodiment of FIGS. 6, 41 and 60-62 is for a stand-alone patientmonitoring device including a oral/nasal cannula 145, a first series ofconnection points from receiving input signals from patient monitoringconnections and a connector 151 for receiving a supplemental 02 supply152.

A second expression of the embodiment of FIGS. 6, 41, 60-62 is for a BMU300 that accepts user inputs of patient and procedure data including agraphic user interface 212. In this application, BMU 300 may be used forinputting and displaying patient parameters (such as physiologicalparameters) during a pre-procedure set-up, a surgical procedure orduring post-procedure recovery.

A third expression of the embodiment of FIGS. 6, 41, 60-62 is for a BMU300 that provides for the delivery of audible commands to patient 10including a ARM module 340, an audible output through oral/nasal cannula145 and earpiece 135 vibratory handset 342 and input cable 150.

In one implementation of the third expression, during a pre-procedureset-up BMU 300 provides an audible command to patient 10 via ear piece135, such as “squeeze left hand” and monitors the response time toestablish a baseline response rate. In one illustration of theimplementation cannula 145 provides for the delivery of audible commandsto a patient 10 requesting a response for an Automated ResponsivenessMonitor (ARM) 340.

A fourth expression of the embodiment of FIGS. 6, 41, 60-62 is for a BMU300 in combination with a procedure room unit including a oral/nasalcannula 145, a first series of connection points from receiving inputsignals from patient monitoring connections and a second series ofconnection points for outputting patient parameters and a display screenfor displaying patient parameters. In one implementation of the fourthexpression umbilical cable 160 connects to BMU umbilical cable connector151 (in lieu of connection to supplemental O₂ supply 152) andcommunicates patient parameters from BMU 300 to PRU 200. In oneillustration BMU 300 travels with patient 10 to a procedure area.Umbilical cable 160 connects BMU to PRU 210 and BMU 300 downloads allpatient input data and parameters (inclusive of physiological parametersand CO₂ readings) to PRU 210. PRU 210 initiates O₂ delivery to thepatient (as required) via cable 160.

In a fifth expression of the embodiment of FIGS. 6, 41, and 60-62, BMU300 monitors user inputs of patient parameters and includes patientinformation on graphic user interface 212 during post-procedurerecovery. In this application, BMU 300 may be used for displayingpatient parameters (such as physiological parameters) during apost-procedure recovery, providing an O₂ supply, if required andallowing medical personnel to assess the condition of patient 10 priorto release. In one implementation of the fifth expression, BMU 300includes a light bar 208 of multiple LEDs for easy viewing by medicalpersonnel. Light bar 208 is able to convey patient condition indifferent formats, such as green lighting, red lighting and yellowlighting, blinking lights and steady state lights.

In a second implementation of the fifth expression, BMU 300 utilizes ARMmodule 340 and ARM handset 342 to automatically query the patient andrecord time-based responsiveness replies and combine the responses withother monitored parameters to conduct patient assessment.

The following paragraphs present a detailed description of oneparticular enablement of the embodiment of FIGS. 6, 41 and 60-62. It isnoted that any feature(s) of this particular enablement can be added toany of the previously-described expressions (including examples, etc.thereof) of the embodiment of FIGS. 6, 41 and 60-62. In this enablementBMU 300 provides for monitoring of patient physiologic parameters duringall phases of a procedure. When BMU 300 is connected to PRU 200 viaumbilical cable 160 in the procedure room, the physiologic parametersmonitored by BMU 300 are displayed on PRU 200. BMU 300 contains BMU hostcontroller 301, which is the computer for the unit. BMU host controller301 includes both hardware and software components. The hardwarecontains interface components for communicating with the patientmonitors. This communication includes receiving patient data, monitoringoperating status, and sending routine commands to the modules. Thesoftware processes the data received from the patient monitors fordisplay on the visual display monitor. The software contains drivers forthe visual display monitor, touch screen, speakers, ARM functions,internal memory, and printer. BMU 300 is designed to stay with thepatient throughout the procedure flow from the pre-procedure room to theprocedure room and finally to the recovery room.

BMU 300 contains electrocardiogram (ECG) module 330, which containselectronics, and software used to process patient signals as suppliedthrough ECG pads 332 and ECG leads 334. ECG pads 332 and ECG leads 334are well known in the medical. One example of ECG module 330 isavailable from Mortara Instrument, Inc., Milwaukee, Wisc., Model M12A.The resultant data from this module are then sent to BMU host controller301 for display of patient physiologic parameters (heart rate and waveform).

BMU 300 also contains non-invasive blood pressure (NIBP) module 320.NIBP module 320 includes NIBP pump 322. One example of NIBP module 320is available from SunTech Medical Instruments, Inc., Morrisville, N.C.,Model MC2619045. Non-invasive blood pressure (NIBP) module 320 containsthe electronic components, software, pump, and valves used to inflatenon-invasive blood pressure (NIBP) cuff 321. NIBP cuffs are well knownin the medical arts. The electronic components process the informationreceived through NIBP cuff 321 with software. The resultant bloodpressure data (systolic, diastolic pressures) are then sent to BMU hostcontroller 301.

Pulse oximeter (SpO₂) module 310 is also contained within BMU 300. Oneexample of pulse oximeter module 310 is available from Dolphin Medical,Inc., Hawthorne, Calif., Model OEM701. Pulse oximeter module 310contains the electronic components and software used to process patientinformation received through reusable pulse oximeter probe 311. Oneexample of pulse oximeter probe 311 is available from Dolphin Medical,Inc., Hawthorne, Calif., Model 210. The resultant data (pulse rate,SpO₂, and wave form) are sent to BMU host controller 301.

Also located within BMU 300 is automated responsiveness monitor (ARM)module 340. Arm module 340 includes ARM speaker assembly 341. During aprocedure, ARM module 340, which includes hardware and software,provides simultaneous audible and tactile stimuli via earpiece 135 and avibratory ARM handset 342 to the patient. Arm handset 342 isergonomically designed to fit comfortably in the hand of the patient andheld in the palm by a retaining strap. The stimuli continue for up to afixed period of time, or until the patient responds by squeezing ARMhandset 342 which activates a mechanical switch within the handset andsends a signal to ARM module 340. The ARM audible stimulus is a request(“please squeeze your hand”) and a mild vibration of ARM handset 342. Ifthe patient fails to respond a more urgent audible request is repeated(“squeeze your hand”) and the vibration intensity is increased, whichmay include an increase in audible volume. If the patient again fails torespond an even more urgent audible-request is repeated (“squeeze yourhand now!”) and ARM handset 342 vibration intensity is increased a thirdand final time. If the patient fails to squeeze ARM handset 342 duringthis sequence the patient is deemed non-responsive. If the patient doesnot respond within the fixed period of time, the monitoring shell takesaction and alerts the care team.

Oral/nasal cannula 145 attaches to the patient at one end that includesthree gas sampling ports, one for the left nostril, one for the rightnostril, and one for the mouth. The patient end also includes nasal andoral outlets for oxygen delivery. The other end of oral/nasal cannula145 connects to BMU 300 via cannula connector plate 304. Cannulaconnector plate 304 fluidly connects outputs from oral/nasal cannula 145with BMU 300. Cannula connector plate 304 also connects outputs from BMU300 with oral/nasal cannula 145. Within BMU 300 is located a pressuretransducer (which, in one example, is a nasal pressure transducer 47)which functions to detect when the patient is inhaling or exhaling andcommunicates to PRU 200 to control oxygen flow. Oral/nasal cannula 145also includes earpiece 135, which delivers audible respond commands tothe patient from ARM module 340.

A power button 318 is located on the face of BMU 300, illuminates greenwhen BMU 300 power is on, and pulses green when BMU 300 is in standbymode. BMU 300 includes a user interface that relays information gatheredfrom the physiologic monitors and sensors to the user and allows theuser to enter information and commands to the control system. BMUGraphic User Interface (GUI) 212 includes a backlit LCD visual displaymonitor with a touch screen for user input and an alarm system withaudio and video components. Speaker 216, for providing audibleindicators to the user, is located on the face of BMU 300. A light bar208 is located on the top portion of BMU 300, is molded from asemi-transparent thermoplastic (e.g., polycarbonate), and is illuminatedby LED's 203 to provide visual indication of alarm conditions. The lightbar 208 is particularly useful to convey information to medicalpersonnel in the post-procedure room where numerous patients may berecovering from surgical procedures and numerous BMUs are present. Whenpatient physiology crosses alert and alarm thresholds, the digitaldisplay indicates the alarm condition. In addition to the visualindicators, the BMU incorporates distinct audible tones for alarms.Light bar 208 may, for example, display or flash green when the BMU 300does not detect any abnormalities or display or flash yellow when analert occurs or display or flash red when an alarm occurs. Further,light bar 208 may change color, intensity and flashing cycle to portrayventilation magnitude and/or status. Light bar 208 may also includealpha, numeric or alphanumeric displays. Such displays may provideadditional detailed information such as heartbeats per minute,respiration rate or alarm details.

A separate thermal printer may be used to create a hard copy record ofsedation information. Printer port 218 is provided on the side of BMU300 for connection of a remote printer. BMU 300 can operate on eitherinternal battery power by utilizing BMU batteries 303 or through anexternal a/c power adaptor. Further, BMU 300 receives power from PRU 200when they are connected in the procedure room. An oxygen adaptor 152 andtubing set can be connected between BMU 300 and a standard oxygen walloutlet or oxygen tank to allow oxygen to be conveniently provided to apatient through BMU 300 when BMU 300 is not connected through umbilical160 to PRU 200 (typically pre-procedure and recovery).

As best illustrated in FIG. 62, the internal components of BMU 300 aresandwiched between top foam support 312 and bottom foam support 313. Inone example, foam supports 312 and 313 are constructed of rigid foamwell known in the electronics industry as an E-PAC™ chassis.Strategically located recesses and cavities in the E-PAC™ chassisefficiently capture and securely hold pc boards, pump, LCD, speaker, andother components. The outer housing of BMU 300 is constructed of rigidmolded thermoplastic (e.g., ABS) and includes bottom 314, front 315,back 316, and top 317. The housing components are held together withmolded-in snap features and screws. Housing top 317 is designed to bereadily removable for access to batteries 303.

Sedation Delivery System

Referring to FIGS. 63-76, the following paragraphs present onecombination of particular examples of the previously-described aspectsof the invention and is for a sedation delivery system (SDS) 100, whichis an integrated monitoring, and drug delivery system and which isintended to provide a means of sedating a patient during medicalprocedures. SDS 100 uses a drug delivery algorithm called DosageController (DC) and an intravenous infusion pump 220 to deliver drug(s)with a variable rate infusion that rapidly achieves and maintains adesired sedation effect. It enables the physician/nurse(non-anesthesiologist) care team to adjust the patient's sedation levelby simply entering the dose rate that they believe will maintain thedesired sedation effect. DC calculates the appropriate loading dose,based on the guidelines in the drug labeling, that will rapidly achievethe sedation effect for the given maintenance rate.

SDS 100 includes four routine physiologic monitors. These are a pulseoximeter 110 for monitoring the patient's arterial oxygenation,non-invasive blood pressure (NIBP) 120 and electrocardiogram pads (ECG)332 for monitoring the patient's cardiodynamics, and a capnometer 140and 202 for measuring the patient's respiratory activity. In addition,SDS 100 has an automated responsiveness monitor (ARM) 150 to aid thecare team in assessing the patient's level of sedation. All fivemonitors and DC are integrated together through a software modulereferred to as the monitoring shell. The monitoring shell is intended tokeep the patient at the desired level of sedation. It monitors thepatient's condition, keeps the care team informed of the patient'sstatus, and immediately stops the delivery of drug(s) if it detects anundesired sedation condition. Under certain circumstances, themonitoring shell will re-initiate drug delivery, but at a reducedmaintenance rate, once the patient's condition returns to a desiredsedation condition. The monitoring shell will not re-initiate infusionif such inaction is warranted by the undesired sedation condition.Instead, it requires intervention by a care team member to re-initiatedrug delivery following such a condition. An integral part of themonitoring shell is procedure room unit (PRU) Graphical User Interface(GUI) 210 and bedside monitoring unit (BMU) graphic user interface 212;each displays the monitored physiologic values in a fashion that enablesthe care team to readily determine the status of the patient. The GUIhas also been designed to give the care team an efficient means ofadjusting the patient's level of sedation through changes in themaintenance rate.

SDS 100 is designed to provide continuous hemodynamic monitoring of thepatient in the pre-procedure room, the procedure room, and the recovery(post-procedure) room. It includes two main units, which are the bedsidemonitoring unit (BMU) 300 and the procedure room unit (PRU) 200. BMU 300is connected to the patient in the pre-procedure room and stays with thepatient through recovery. BMU 300 contains pulse oximeter module 310,NIBP module 320, ECG module 330, and ARM module 340. Once connected tothe patient, it monitors and displays the patient's arterial saturation,arterial pressure, and heart rate. Supplemental oxygen (which includesair having an enriched oxygen content) can be delivered at this timethrough BMU 300 and oral/nasal cannula 145. When the patient is wheeledinto the procedure room, BMU 300 is attached to PRU 200 by umbilicalcable 160, which contains both pneumatic and electrical lines. Duringthe procedure, umbilical cable 160 allows PRU 200 to receive patientphysiologic data from BMU 300 as well as the patient's respiratorygases. In addition, umbilical cable 160 allows for delivery of oxygen tothe patient from PRU 200.

PRU 200 adds capnography to the system, monitoring and displaying thepatient's respiration rate and end-tidal CO₂. ARM monitoring isactivated and the patient's responsiveness is displayed to the careteam. As soon as PRU 200 detects respiration activity (from thecapnometer), mandatory oxygen delivery is initiated. All drug deliveryis performed by PRU 200 as it contains intravenous infusion pump 220, DCand the monitoring shell. Drug infusion cannot be initiated until allmonitors are connected and providing valid values and oxygen is beingdelivered to the patient. PRU 200 is the main interface between the careteam member responsible for administering sedation and SDS 100. Itcontains GUI 210 that displays the status of the patient and facilitatesadjustment of the patient's level of sedation.

Referring now to FIGS. 42 and 43, PRU 200 is a component of the systemthat provides for: monitoring and display of patient physiologicparameters; user input of patient data; user input of dose rate; andhardware and software for delivery of drug(s) during the procedure. PRU200 is designed to stay in the procedure room and is the mechanism fordrug delivery.

Within PRU 200 are located two capnometers 140 and 202 used for samplingCO₂ from the areas in front of the patient's mouth and nostrils.Software monitors respiratory activity and the site with the greaterrespiratory activity is displayed to the user. Sensors analyze thesamples, and the resultant data (respiratory rate, EtCO₂, andrespiration wave form) are sent to PRU host controller 204.

Sedation Delivery System 100 is an apparatus for delivering a sedativedrug to a patient during a medical procedure. The amount of sedativedrug delivered to the patient is determined by the level of patientresponsiveness as measured by ARM system 340. In an alternateembodiment, the level of pain a patient is enduring determines theamount of sedative drug delivered to the patient. Patient pain level canbe indicated by physiological parameters, such as, increased heart rateand/or blood pressure and/or brain activity. Sedation Delivery System100 includes the capability to monitor heart rate through the ECGmonitor and blood pressure by way of the NIBP monitor. An EEG(brainwave) monitor is optionally supplied with Sedation Delivery System100 to monitor a patient's brain activity. Sedation Delivery System 100therefore interprets an elevated output from the ECG, NIBP, and/or EEGas an indication that the patient is experience pain or stress andadjusts the drug delivery to better manage the patient. For example,Sedation Delivery System 100 will increase drug flow to the patient ornotify the clinician to increase drug if any of ECG, NIBP, and/or EEGmonitors increase by a predetermined threshold, for example, 20% in apredetermined time period. Other monitored physiological parameters arewithin the scope of this embodiment as is well appreciated by thoseskilled in the art.

Referring to FIGS. 42 through 47, Infusion pump 220 is located in thefront portion of PRU 200 and provides for the delivery of drug(s).Disposable cassette 251 interfaces with pump 220. Cassette 251 holds adrug vial 250 from which drug(s) is delivered to the patient. Cassette251 includes a base plate holding vial spike 261, infusion tubing 277 &259, and t-site luer connector 269 located at the patient end of theinfusion tubing. As illustrated in FIG. 44, pump door 201 on PRU 200opens to accept cassette 251 and secures cassette 251 into properposition with pump 220 when closed. T-site sensor 226 is an optical typesensor located in Pump 220 that is used to signal PRU host controller204 of the presence of T-site 269 when cassette 251 is installed.Another optical type sensor located in pump 220 is vial sensor 228. Itis used to signal PRU host controller 204 of the presence of a drug vial250. Air-in-line sensor 225 is an ultrasonic device that straddles ashort segment of tubing 277 and detects the presence of air or airbubbles being pumped through tubing 277 from the drug vial. Occlusiondetector 223, located in pump 220, is a small pressure transducer thatrests against tubing 277 to detect an increase in the tubing internalpressure indicating a possible occlusion in infusion tubing 259. Pumpfingers 229 interface with a segment of tube 277 located across the topof cassette 251 and their peristaltic pumping action pumps drug(s) fromthe drug vial 250 through tubes 277 & 259 and to the patient. Pump 220is driven by software on electronic circuit boards that interface withPRU host controller 204.

FIG. 45 further illustrates the proper location of cassette 251 in pump220 and shows pump door 201 open. FIG. 46 illustrates cassette 251 inpump 220, door 201 closed, and a drug vial 250 in position to be placedon vial spike 261. FIG. 47 illustrates cassette 251 inserted into pump220, door 201 closed, and a drug vial 250 placed on vial spike 261.

Referring again to FIGS. 42 and 43, located within PRU 200 is oxygendelivery module 206, which controls the delivery of oxygen to thepatient during the procedure. Oxygen delivery module 206 containssensors, flow control devices, and tubing that provide for oxygendelivery. One of the sensors measures the concentration of oxygen in theline coming into PRU 200, and, if the concentration of oxygen is below apredetermined level, oxygen delivery is not permitted and a message isdisplayed to the user. This feature is intended to help prevent deliveryof a gas other than oxygen to the patient.

PRU graphic user interface (GUI) 210 allows PRU 200 to relay informationgathered from the physiologic monitors and sensors to the user andallows the user to enter information and commands. PRU graphic userinterface 210 includes a visual display monitor with a touchscreen foruser input and an alarm system with audio and video components. Inaddition, a printer is used to create a hard copy record of sedationinformation. When the monitored patient physiologic measurements arewithin desired parameters, an alarm box area of the monitor displaysgreen. When the respiratory rate or oxygen saturation (SpO₂) is outsidea desired state by a first amount, their respective status bar indicatesa first alarm condition by displaying it in the color yellow. When thesesame physiologic parameters are outside the desired state by a largersecond amount, the respective status bar indicates a second alarmcondition by displaying red. In addition to the visual indicators, SDS100 incorporates distinct audible tones for different alarm levels(i.e., yellow or red).

PRU 200 is powered by universal power supply (UPS) 214, which convertsavailable a/c voltage to constant DC voltage. This voltage is providedto all modules within SDS 100. UPS 214 also includes a battery poweredback-up system that allows the user several minutes of system use timein the event of a power failure.

PRU 200 includes PRU host controller 204 which has both hardware andsoftware modules. The hardware contains interface components forcommunicating with all of the patient monitors. This communicationincludes receiving patient data, monitoring operating status, andsending routine commands to the modules. The software also processesdata received from the patient monitors for display on the video displaymonitor. The software contains drivers for the display, touchscreen,speakers, internal memory, printer, ARM functions, Ethernet port,external video display, internal sensors, and infusion pump 220.

Operating software controls the interaction and function of SDS 100.Through the monitoring shell, the software makes pertinent decisionsbased on information it receives from user input, various internalsensors, and patient monitors. If the patient status reaches a leveloutside of desired limits for conditions associated with deeper thandesired sedation (e.g., low respiratory rate or low oxygen saturation),the software takes appropriate action alerting the user and decreasingor stopping the administration of drug(s). The software also executesdelivery of drug(s) based on the dose rate prescribed by the user. Theinfusion model is based on pharmacologic principles and uses patientweight along with desired dosage to calculate the infusion rate ofdrug(s).

As a user convenience, SDS 100 contains software to automatically primethe patient infusion line 224 when a valid drug delivery cassette anddrug vial is loaded into infusion pump 220. As a monitoring feature,with cassette 251 installed into infusion pump 220, a sensor detects thepresence of the t-site connector installed on drug delivery cassette 251. The SDS primes the infusion line 224 when the t-site is detected asbeing attached to the drug delivery cassette.

The following paragraphs present particular examples of several SDS I 00functional subsystems comprising components of one or more of thepreviously-described aspects, and the one previously-describedcombination of particular examples of aspects, of the invention.

The oxygen delivery functional subsystem accepts supplemental oxygenfrom a standard user-provided external source and dispenses it to thepatient in a controlled flow pattern that is influenced by the patient'sbreathing pattern. When the patient is breathing primarily from a nasalaspect, the oxygen is at a higher flow rate during inhale and at a lowerflow rate during exhale. When the patient is breathing primarily orally,the oxygen is turned on continuously. The flow rate is adjustable by theuser input to the PRU GUI 210. The oxygen is delivered to the patient bymeans of the oral/nasal cannula 145, which includes a specializedmask-like portion that is affixed to the oral/nasal zone of thepatient's face.

The oxygen flow is controlled within the PRU console 444 in accordancewith algorithms that are influenced by the patient's nasal pressure. Themetered oxygen flow produced by PRU console′ 444 is presented to and fedthrough the umbilical cable 160 to the BMU 300. The BMU 300 presents theoxygen to a single-use disposable called the oral/nasal cannula 145 thatis attached to the BMU 300. The oral/nasal cannula 145 conveys theoxygen to the patient, via its oxygen tube 353, and dispenses the oxygento the patient's nasal and oral zones via two nasal oxygen prongs 422and one oral prong 369.

The oxygen delivery functional subsystem has several ancillary oxygenrelated functions, which are primarily resident within the PRU console444. These functions include a means to verify that the supplementaloxygen supply is not hypoxic and is not at an oxygen content lower thanambient air. In the event of detection of hypoxic gas, the PRU console444 will shut off gas delivery to the patient and alert the user.Another ancillary oxygen function is protection against inadvertentlyhigh pressure supplemental oxygen acquired from the user's supplementaloxygen source, which is mitigated via pressure release blow-off of theexcessive pressure. Another ancillary oxygen function is protectionagainst inadvertently high oxygen pressure in the relatively lowpressure oxygen flow path, which is mitigated via pressure releaseblow-off of the excessive pressure. Another ancillary oxygen function isthe detection of a disconnected umbilical pneumatic cable connector endA 161 or umbilical pneumatic cable connector end B 162 at either the PRUconsole 444 or at the BMU 300 or the disconnection of the oral/nasalcannula 145 from the BMU 300. When the oral/nasal cannula 145 isdisconnected from the BMU 300, the oxygen is not delivered to theintended patient site. This disconnection is detected by PRU console444's observation of the unexpected pressure level measured in theoxygen delivery path. When detachment is discerned, the oxygen deliveryis automatically ceased by the PRU console 444 until the detachment isresolved by the user. Another ancillary oxygen function is thehand-operated oxygen gas valve called the oxygen diverter 492 at therear of the PRU console 444. The oxygen diverter 492 permits the user toconveniently manually divert the incoming supplemental oxygen away fromthe PRU Console 444 interior and instead present that oxygen supply toan SDS-system-bypass oxygen source fitting referred to as the barbedoxygen outlet 494. The barbed oxygen outlet 494 permits the user toaccess oxygen via the SDS 100 for use with alternate oxygen careequipment, such as would be utilized to bypass the SDS system.

The oxygen manifold 206, located in the PRU console 444, is a metallicstructure containing internal hollow pathways that provides an efficientmeans for routing the supplemental oxygen to or through oxygen-relatedmeasurement and control devices that are mounted to the oxygen manifold206 or are not mounted to the oxygen manifold 206 but are plumbed to theoxygen manifold 206. The supplemental oxygen is attached by the user toa coupling on the oxygen manifold 206 referred to as the oxygen inputcoupler 484, which is located at the rear of the PRU console 444. Thisincoming oxygen has its pressure measured by a high side pressure sensor487, located on the oxygen manifold 206 that monitors the high sidepressure and presents that data to the PRU host controller 204. Thisincoming oxygen is also presented to a high side pressure relief valve485, located on the oxygen manifold 206, which will exhaust excessivepressure to the ambient atmosphere. This incoming oxygen is alsopresented to an oxygen sample solenoid 481 that is normally closedexcept during sampling. Whenever the PRU console 444 checks the incomingoxygen for possible hypoxic content, the oxygen sample solenoid 481 ismomentarily opened. This presents a stream of incoming oxygen that isblown down an ancillary gas path past the oxygen sensor 482 andsubsequently exhausted out of the oxygen manifold 206 to the ambientatmosphere. The PRU host controller 204 compares this sample to theoxygen content of the ambient air, having measured ambient air oxygenconcentration prior to or after incoming oxygen sampling. If theincoming oxygen sample has a higher content of oxygen, then thesupplemental oxygen connected to the PRU console 444 is deemednon-hypoxic and is permitted to be utilized by the SDS 100.

The incoming oxygen primary gas path continues into the oxygen diverter492. The oxygen diverter 492 normally allows the oxygen to pass throughalong the primary gas path. However, if the oxygen diverter knob 493 isin the SDS-system-bypass position, the oxygen is instead directed awayfrom the primary gas path and rather is directed into an oxygen externaloutput orifice 478 that serves as a flow restrictor. Then the oxygengoes to an external nozzle referred to as the barbed oxygen outlet 494.The primary oxygen path proceeds to the fixed restrictor 489, which is asingle size orifice that provides a controlled restriction of oxygenflow and produces a resulting differential pressure across the orificethat is proportional to flow rate through the fixed restrictor 489. Thedifferential pressure, as seen on each side of the fixed restrictor 489,portrays the oxygen flow rate in the primary gas path; whereby the flowis implicitly measured via a pair of tubes that convey these twopressures to a differential pressure sensor 479 that is located on thesystem input/output (1/O) board. The differential pressure transducer479 provides the oxygen pressure data to the PRU host controller 204.The PRU host controller 204 determines the implied oxygen flow ratethrough the fixed restrictor by means of mathematical formulae andtabulated correlation data.

The oxygen proceeds past the fixed restrictor 489 and proceeds into avoltage sensitive orifice (VSO) solenoid, referred to as VSO Solenoid480, which has an orifice size that is proportional to the voltageapplied to its actuator coil. The VSO variable gas flow restrictionprovides for the PRU console 444 control of the oxygen gas flow rate,including the complete shut-off of oxygen flow when appropriate. The VSOsolenoid 480 is operated by the PRU host controller 204 in accordancewith the oxygen control algorithm, utilizing a hardware/softwarefeedback loop that includes the differential pressure sensor 479. Theoutput of the VSO solenoid 480 is presented to a low side pressuresensor 488 that monitors the low side pressure and presents that data tothe PRU host controller 204.

The primary gas path continues past a low side pressure relief valve 486which will exhaust excessive pressure to the ambient atmosphere. Theoxygen exits the oxygen manifold 206 at a fitting, which has flexibletubing, connected to it. This flexible tubing conveys theflow-controlled oxygen over to the PRU umbilical cable pneumaticreceptacle 462 located at the front of the PRU console 444. One of thechannels of the PRU umbilical pneumatic receptacle 462 is dedicated foroxygen delivery. The umbilical cable 160 is attached by the user to thePRU umbilical pneumatic receptacle 462. The controlled flow oxygen istransported along the umbilical cable 160 via a dedicated oxygen tubingline within the umbilical cable 160 where it is delivered at the otherend of the umbilical cable 160 into the BMU 300.

The capnometry functional subsystem (CFS) provides the means to measureand display the patient's exhaled CO2 levels, end tidal CO2 (EtCO2), andrespiration rate (RR). This CO2 related data is presented on the PRUscreen in the form of a CO2 graph, EtCO2 value, and RR value that isupdated on a breath-to-breath basis. The CFS collects patient exhalesamples of the nasal and oral site, monitors patient nasal exhalevelocity, analyzes the exhale samples for CO2 content, selects the mostrobust CO2 data, whether it be nasal or oral, in accordance withalgorithms that then display the most robust data and derivatives ofthat data on the PRU Monitor.

Ancillary functions of the CFS include detection of occluded orpartially occluded exhale sample air line, filtration to guard againstintrusion of air-borne particulate that could effect the measurementsensor, extended capacity trapping of water condensate precipitatingfrom the sampled air, and reduction of sampled air humidity to avoidprecipitation of fluid in the measurement sensor.

The cannula has two nasal exhale sample ports, left and right nostrilthat are inserted into the patient's nostrils. Each sample port has itsown dedicated sample line tube that extends to the cannula SPU(single-patient-use) connector. The cannula SPU connector body joins thesample paths of these two tubes into a singular sample path where mixingof the two samples occurs. At this point, a singular nasal-dedicatedwater trap is employed to separate out precipitate that is present. Thecombined nasal sample is presented at the nasal exhale sample output ofthe SPU cannula connector. There are also two additional tubes emanatingfrom the left and right nasal sample ports, which convey the pressure ofthese two ports over to the cannula SPU connector. These two pressuresignals are conveyed discretely to the output of the cannula SPUconnector without combining with each other.

The cannula has one oral exhale sample port that is positioned in frontof the mouth. This sample port has its own dedicated sample line tubethat extends to the cannula SPU connector. At this point, anoral-dedicated water trap is employed to separate out precipitate thatis present. The oral sample is presented at the oral exhale sampleoutput of the cannula SPU connector.

The BMU cannula connector accepts the cannula SPU connector andassociated nasal/oral exhale samples and nasal pressure signal. Thenasal exhale sample is conveyed, via tubing, through the BMU and ispresented at the BMU umbilical pneumatic receptacle as a singlepneumatic line in that connector. The oral exhale sample is conveyedthrough the BMU and is presented at the BMU umbilical pneumaticreceptacle as a single pneumatic line in that connector. The nasalpressure sample is terminated within the BMU at the nasal pressuresensor. The nasal pressure sensor signal is measured by the BMUexpansion board, which conveys the nasal pressure signal data to the PRUconsole 444 via the BMU umbilical electrical connector and associatedumbilical cable.

The oral and nasal exhale samples are transported through oral and nasaltransport tubing lines in the umbilical cable. Those samples aredelivered to the PRU umbilical pneumatic receptacle, which conveys theseexhale samples to the inside of the PRU console 444.

The nasal exhale sample is then directed into a hydrophobic filter thatprevents airborne particulate and water droplets from proceeding furtherinto the system. The filtered exhale sample is fed, via tubing, to thenasal capnometer module. The nasal capnometer module performs CO2measurements upon the exhale sample as it passes through the capnometerCO2 sensor. The nasal capnometer is an OEM (original equipmentmanufacture) device, made by Cardio Pulmonary Technology Inc, partnumber CO2WFA. It contains an infrared (IR) sensor, control electronics,pressure sensor, and pneumatic reservoir. The exhale sample exits thenasal capnometer module and travels via tubing to the nasal capnometerpump 141 which is located in the E-PAC™ chassis within the PRU console444. The nasal capnometer pump 141 provides the vacuum that ispropelling the sample from the cannula into the PRU console 444. Thenasal capnometer pump 141 is controlled by the nasal capnometer modulecontrol electronics, which controls and regulates the air flow to atarget flow rate. The nasal exhale sample passes through the nasalcapnometer pump 141 and then passes through tubing to an exit portlocated within the PRU console 444 where that gas is diluted with thePRU console 444 enclosure air that is being circulated by the PRUconsole fan.

The oral exhale sample is directed into a filter that prevents airborneparticulates from proceeding further into the system. The filteredexhale sample is fed, via tubing, to the oral capnometer module. Theoral capnometer module performs CO2 measurements upon the exhale sampleas it passes through the capnometer CO2 sensor. The oral capnometer isan OEM device, made by Cardio Pulmonary Technology Inc, part numberCO2WFA. It contains an infrared (IR) sensor, control electronics,pressure sensor, and pneumatic reservoir. The exhale sample exits theoral capnometer module and travels via tubing to the oral capnometerpump 142 which is located in the E-PAC™ chassis within the PRU console444. The oral capnometer pump 142 provides the vacuum that is propellingthe sample from the cannula into the PRU console 444. The oralcapnometer pump 142 is controlled by the oral capnometer module controlelectronics, which controls and regulates the air flow to a target flowrate. The oral exhale sample passes through the oral capnometer pump 142and then passes through tubing to an exit port located within the PRUconsole 444 where that gas is diluted with the PRU console 444 enclosureair that is being circulated by the PRU console fan.

The nasal pressure subsystem monitors the patient nasal exhale pressureand the corresponding pressure data is employed in a nasal pressurealgorithm to determine when the patient is deemed to be in a nasalbreathing mode or an oral breathing mode.

The cannula body has two nasal pressure measurement channels, one foreach nostril. The pressure encountered by each nasal channel by thecannula body is conveyed by two independent pneumatic lines to thecannula connector that is attached by the user to the respective BMUreceptacle. These two pneumatic lines are combined together as asingular pneumatic pressure signal at the cannula connector. Thesingular nasal pressure signal is conveyed into the BMU. This nasalpressure is conveyed by a single tube to a BMU pressure sensor locatedinside the BMU. The BMU pressure sensor measures the relative nasalpressures presented to the cannula body and converts this analogouspressure to an electrical signal that is processed by the BMU expansionboard and communicated via the umbilical cable to the host controller inthe PRU.

The PRU host controller utilizes algorithms to analyze the pressuresignal and thereby produces synchronization signals that provide timingcues relating to specific events, namely, when the nasal inhale hasbegun and when the nasal inhale has ceased and when the nasal exhale hasbegun and when the nasal exhale has ceased. Also, in the event that thepatient is in an oral breathing mode, the nasal pressure signal issufficiently weak to be recognized by these algorithms and produces acue for the PRU host controller that indicates the oral breathing mode.

These nasal inhale/exhale timing cues and oral inhale/exhale timing cuesare utilized by the respiratory functional subsystem to coordinate timeddelivery of variable flow rate oxygen and also coordinate selection oforal or nasal capnometer data for use in displayed CO2 waveform, EtCO2calculation and display, and respiration rate calculation and display.

The respiratory functional subsystem includes the supplemental oxygensubsystem, the capnometry functional subsystem, and the nasal pressuresubsystem. These subsystems operate in a coordinated fashion by means ofsystem level algorithms and control programs.

When the patient is in an oral breathing mode, the oxygen deliverysubsystem is directed to set the oxygen flow to a present continuousflow rate. When the patient is in a nasal breathing mode, the oxygendelivery subsystem is directed to gate the oxygen flow between a fastand a slow flow rate in synchrony with the patient inhale/exhale timing.This synchrony is performed by means of the nasal pressure subsystemfunction to determine when the nasal inhale has begun and when the nasalinhale has ceased and when the nasal exhale has begun and when the nasalexhale has ceased. These inhale/exhale begin/cease detection means serveas cues for the control of step changes in oxygen flow rates. Thus, theoxygen delivery is a varying flow rate in synchrony with the patient'srespiratory cycle.

The drug delivery functional subsystem provides a means for controlleddelivery of drug(s) from the drug vial 250 installed in the PRU console.The drug pumping means includes an IV pump module that operates inconjunction with an installed cassette. The drug pumping rate iscontrolled by commands issued to the IV pump module from the PRU hostcontroller.

Ancillary functions of the drug delivery functional subsystem includepump door lock/unlock, detection of the T-site commercial luer positionwithin the designated home location of the cassette, detection of thepresence of the drug vial seated within the cassette, air-in-linedetection for detecting air in the IV line, detection of occlusion ofthe IV line, and an undesired-pumping detection monitor.

The pump is enabled when the T-site commercial luer is seated within thecassette. The pump door can be opened when the T-site commercial luer isseated within the cassette.

The umbilical cable power control subsystem (fast switch and statecircuit) includes the umbilical cable in conjunction with PRU consolefast switch, PRU state circuit, BMU fast switch, BMU state circuit, andthe PRU host controller.

The umbilical cable conveys power from the PRU to the BMU. The powerprovided to the BMU is for powering the BMU related circuitry includingthe recharging of the BMU battery. The umbilical cable utilizes a powermanagement control subsystem that permits the “hot swap” of theumbilical cable while the equipment is energized. The umbilical cablepower management disconnects power when the umbilical cable connectorhas become slightly disengaged from full connection. This helps preventany spark during detachment of the umbilical cable and also helpsprevent the umbilical cable connector contacts from being overlystressed due to insufficient connector engagement. These power-ceasingmitigations are implemented regardless of which end of the umbilicalcable is detached. These functions are provided by means of a jumperlocated at each end of the umbilical cable, which straps between theshortest pin, called the fast pin, in the connector, and the powerreturn pin of the connector. The strap located at the first end of theumbilical cable is detected by the PRU console fast switch. The straplocated at the second end of the umbilical cable is detected by the BMUfast switch.

Upon disconnection of the umbilical, the fast pin is the first pin tobreak contact with the respective receptacle. This triggers therespective fast switch to interrupt power flow through the umbilicalcable power pins.

Another function of one example of the umbilical cable power controlsubsystem is to help shut off power to umbilical cable connector pins ateither end of the umbilical cable when the umbilical cable isdisconnected from the PRU or the BMU. This function is accomplished bymeans of the PRU console fast switch, the PRU state circuit, the BMUstate circuit, and the PRU host controller. In this example, when theumbilical is disconnected from the BMU under nominal conditions, the BMUstate circuit in conjunction with the PRU state circuit detects thedisconnection and the PRU state circuit turns off the PRU fast switch,which disconnects power and communications to the umbilical resulting inno power at the pins of the Umbilical Cable. In this example, in theevent of a non-nominal condition of some aspects of the state circuit,the absence of communications via the umbilical cable is detected andtagged by the PRU host controller as a possible disconnection of theumbilical cable, which evokes a turn-off signal to the fast switch. Thefast switch disconnects both the power and communications lines signalsthat are applied to the umbilical cable.

The following paragraphs present a description of one particularexemplary use of SDS 100 without limiting the scope of the invention. Asshown in FIGS. 77-80, components of SDS 100 are employed throughout asurgical procedure, including pre-procedure set-up and post-procedurerecovery. The patient arrives in the pre-procedure room, step 1200. Anurse or technician mounts BMU 300 to either the bedrail or IV pole,step 1201. BMU 300 is equipped with an IV pole clamp or a quick connectto quickly and easily mount the unit on either the bedrail or IV pole.Once BMU 300 is in place, the nurse or clinician may connect NIBP cuff120 and pulse oximeter probe 110 to the patient, step 1202. Theseconnections are made between the patient and BMU 300. BMU 300 willautomatically begin monitoring parameters such as, for example,diastolic and systolic blood pressure, mean arterial pressure, pulserate, oxygenation plethysmogram, and oximetry value, steps 1203 and1204. The readings taken by BMU300 will be displayed for the nurse ortechnician on BMU GUI 212. While patient parameters are being monitored,the nurse or technician is free to perform other tasks. As is customarywith current practice, the nurse or technician may need to complete apre-procedure assessment, step 1206. The pre-procedure assessment mayinclude recording patient vital signs, determining any known allergies,and determining patient's previous medical history. Once the nurse ortechnician has completed the pre-procedure assessment, step 1206, thenurse or technician may start the peripheral IV by placing a catheter inthe patient's arm, step 1207. The IV catheter is connected to theprimary IV drip device such as, for example, a 500 mL bag of salinefluid. Upon completion of the above activities, the nurse or technicianbegins to attach ECG pads 130, ARM handset 342, ARM earpiece 362 andoral nasal cannula 351 to the patient, step 1208.

Once the patient is connected to the above-mentioned items, the nurse ortechnician may explain ARM system 340 to the patient. This explanationmay involve the nurse or technician instructing the patient to respondto auditory stimulation from earpiece 362 and/or tactile stimulationfrom ARM handset 342 by squeezing ARM handset 342. If the patient failsto respond to either auditory or tactile stimulation, the intensity ofthe stimulation will increase until the patient responds successfully.At this point, the nurse may initiate an automated ARM training, step1209. Automated ARM training is a program run by BMU 300 that teachesthe patient how to detect an ARM stimulus and how to respond to thatstimulus and sets a baseline patient response to the stimulus asdisclosed in the previously referenced U.S. patent application, serialno. 10/674,160. The nurse or technician is free to perform other patientrelated tasks while the patient is participating in the automated ARMtraining. BMU 300 will display the automated ARM training status so thenurse or technician can quickly determine if the patient isparticipating in the automated training. The patient must successfullycomplete the automated ARM training to proceed, step 1210; if thepatient fails to complete the training a nurse or other clinician mustintervene and determine if the patient may continue, step 1210-A. If theclinician decides the user may proceed, then the patient will proceed tostep 1211; if the clinician decides the patient is unable to continue,then the procedure will be canceled, step 1213. The user may customizethe automated ARM training to automatically repeat at specifiedintervals (i.e. 10 minutes) if the patient is required to wait to enterthe procedure room. This will help to instill the newly learnedresponse.

In addition to successfully completing automated ARM training, thepatients parameters must be in an acceptable range, step 1205. Theclinician may decide upon what an acceptable range is by inputting thisinformation into BMU 300 by means of BMU GUI 212. If any one of theparameters being monitored falls outside a given range, the patient willnot be permitted to undergo a procedure until a nurse or other clinicianexamines the patient to determine whether or not the patient maycontinue, step 1205-A. If the clinician decides the patient is able tocontinue, the patient will proceed to step 1211, if the cliniciandecides the patient is unable to continue, then the procedure will becancelled, step 1213. Just prior to leaving the pre-procedure room forthe procedure room, the nurse administers a predetermined low dose of ananalgesic drug, step 1211 such as, for example, a 1.5 mcg/kg ofFentanyl. After the injection of the analgesic drug, the patient isready to be moved to the procedure room, step 1212.

The patient and BMU 300 relocate to the procedure room, step 1220 andare received by the physician (non-anesthesiologist) and procedurenurse. BMU 300 may be connected to PRU 200 via umbilical cable 160 uponthe patient entering the procedure room, step 1221. Upon connection, theNIBP, pulse and oximetry history from the patient will automaticallyup-load to PRU 200 displaying patient history for the last period ofmonitoring. In addition to NIBP and pulse oximeter history, a recordverifying the patient has completed ARM training will also be uploaded.Upon connection of BMU 300 to PRU 200, the BMU GUI 212 changes from amonitoring screen to a remote entry screen for PRU 200. Displayinformation from BMU 300 is automatically transferred to PRU 200.

At this point, the procedure nurse may secure oral nasal cannula 145 tothe patient's face, step 1222, if not already done so in thepre-procedure room. PRU 200 may begin monitoring patient parameters suchas, for example, ARM, ECG, and capnography now that all connectionsbetween the patient and PRU 200 (via BMU 300) are complete, step 1223.PRU 200 will continue monitoring patient parameters such as, forexample, NIBP, pulse, and oximetry, step 1224. Next the procedure nursemay scan the bar code label on the packaging of a drug cassette 251 andplace the drug cassette within PRU 200 and spike a standard drug vial,step 1225 onto vial spike 261. Once the fluid vial and drug cassette 64are loaded correctly, the nurse may autoprime IV tubing 259. In oneembodiment, the procedure nurse would press a button located upon PRU200 to initiate the autopriming, step 1227, or the autopriming may be anautomatic procedure initiated by PRU 200 when all safety conditions aremet. Autopriming is the automatic purging of air from IV tubing 259. PRU200 continuously monitors the autopriming process to determine theoverall success of the autopriming. If PRU 200 fails to properly purgeIV tubing 259, a warning notification is made to the user so that theprocedure nurse may repeat the autopriming sequence until IV tubing 259is successfully purged, step 1227.

Upon successful completion of the autopriming sequence, the procedurenurse may enter the patient weight in pounds while the physician(non-anesthesiologist) may enter the initial drug maintenance dose rateas well as dose method; normal or rapid infusion, step 1229. After thepatient weight and dose rate have been inputted, the physician orprocedure nurse may initiate drug infusion, step 1230. While the drug istaking effect upon the patient, the physician may perform standardprocedure related activities such as, for example, test the scope, andapply any topical anesthetic. Once the drug has taken the desired effectupon the patient, the physician and procedure nurse are free to conductthe procedure, step 1231. Upon completion of the procedure, theclinician may disconnect the drug delivery cassette from the catheter,step 1232 and disconnect the BMU 300 from the PRU 200, step 1233. If theclinician so desires, PRU 200 may print a record of the patient'sphysiological parameters from printer 454 at this time, step 1234.Included on the print out of the procedure record are patient monitoringdata such as, for example, NIPB, pulse oximetry, capnography,respiration rate, and heart rate. Other system events included in theprint out are, ARM competency, ARM responsiveness during the procedure,oxygen delivery history, drug dose, monitoring intervals, drug bolusamount and time, and total drug volume delivered during the procedure.The printout includes a section where the procedure nurse may enternotes, such as, for example, additional narcotic delivered, topicalspray used, Ramsey Sedation Scale, procedure start and finish time,cautery unit and settings used, cautery grounding site, dilationequipment type and size, and Aldrete Score. After printing the patientrecord, the patient may then be moved to the recovery room, step 1235.

The patient arrives in the recovery room 1240 still attached to BMU 300after leaving the procedure room. At this point, BMU 300 may beoperating on either battery or AC power. Upon entering the room, theattending clinician may remove the ECG pads, ECG lead wires, ARMhandset, and earpiece from the patient 1241. Depending upon clinicianpreference and status of the patient, the patient may requiresupplemental oxygen while in the recovery room 1242. If the patient doesrequire supplemental oxygen, oral nasal cannula 145 is left on thepatients face and oxygen is accessed from an external source such as,for example, a headwall or tank via connector 152 and BMU connector 151,step 1243. If no supplemental oxygen is required in the recovery room,the nurse or technician may remove oral nasal cannula 145 from thepatient 1244.

The nurse or technician may now organize ECG leads 334 and ARM handset342 and place near BMU 300 to be used on the next patient 1245.Alternatively, ARM handset 342 may be used for patient for time-basedresponsiveness to queries from ARM. The nurse or technician may need tofill out additional information on the patient record 1246. The nurse ortechnician will most likely write notes describing the patient'scondition during recovery and record NIBP, pulse rate and oximetryvalues of the patient during recovery. ECG pads 332 and oral nasalcannula 145 may be discarded at this point into a standard wastecontainer located in the recovery room 1247. It is important to notethat BMU 300 is still collecting data related to NIBP, pulse rate, andpulse oximetry 1248. The nurse or technician must determine if thepatient is ready to be discharged 1249. Criteria for discharge varyamong patient care facilities, however an Alderate score of 10 is commonfor discharge. Other measures of discharge criteria includeresponsiveness to queries through ARM, skin color, pain assessment, IVsite intact, NIBP, pulse, respiration rate, and oximetry values all mustbe close to the measurement taken in pre-procedure. If the patient doesnot meet any of these criteria, it is recommended that the patientreceive additional monitoring 1248. Once a patient is cleared fordischarge, the nurse or technician disconnects NIBP cuff 58, pulseoximeter probe, and if not done so already, oral nasal cannula 145 andARM handset 342 from the patient 1250. Once all the above is completed,the patient may be discharged from the care facility 1251.

Now referring to FIG. 81, peripheral medical display 1252 receivesprocessed patient data from medical effector system 100′ and thendisplays the processed patient data on peripheral LCD screen 1253.Information that may be displayed includes heart rate, blood pressure,pulse oximetry, capnography, electrocardiogram, and other medicalparameters that are processed by medical effector system 100′. Inaddition to patient data, the peripheral medical display 1252 maydisplay procedural parameters related to the function of medicaleffector system 100′. The functional parameters may include; batterycharge level, duration of the current procedure, patient name, and otherdescriptive patient data, information related to IV pump module 220, thepharmaceutical drug being supplied to the patient and other parameters.Peripheral medical display 1252 further includes the ability to allow amedical practitioner set predetermined parameter limits, which ifexceeded result in an alarm action by peripheral medical display 1252which may be in addition to any alarm generated by medical effectorsystem 100′. The alarm action may be in the form of a flashing lightfrom peripheral light bar 1254, an auditory signal from peripheralspeaker 1255, or a pop-up alarm on peripheral LCD touchscreen 1253.

Peripheral medical display 1252 may also display the output of anothermedical device such as endoscopic camera 1256. Peripheral medicaldisplay 1252 has the capability to simultaneously display the output ofendoscopic camera 1256 as well as patient and procedural data onperipheral LCD touchscreen 1253. This functionality allows a medicalpractitioner to view relevant patient and procedural data withoutdiverting his or her attention from the output of the endoscopic camera.

Peripheral medical display 1252 may also contain a user interface toallow a medical practitioner to alter display settings on the peripheralmedical display 1252. A user interface may be in the form of PRU monitortouchscreen 443 or peripheral monitor LCD touchscreen 1253 located onperipheral medical display 1252. From the user interface, the medicalpractitioner may alter various visualization parameters including;selecting which medical and procedural parameters if any to overlay onthe output of the endoscopic camera. Furthermore, the medicalpractitioner may modify the size and location of the parameter displaysrelative to one another. Additional options available through the userinterface include, selecting the display format or medical parameters(bar graph, gauge, histogram, pictorial, or numeric), color adjustment,establishing a schedule to automatically change visualizationparameters, establishing a priority of displays in the event of an alarmaction, magnification of the output of the endoscopic camera, andselection of an alternate video source, as well as other visualizationoptions. The patient and procedural parameters may be located apart fromthe output of endoscopic camera 1256 or may be overlaid on the output ofendoscopic camera 1256. This is accomplished by a video mixing apparatuslocated in either peripheral medical display 1252 or medical effectorsystem 100′. Similarly peripheral medical display 1252 may utilize apicture-in-picture display incorporating the output from endoscopiccamera 1256 or other video source.

While aspects, embodiments and examples, etc. thereof, it is not theintention of the applicants to restrict or limit the spirit and scope ofthe appended claims to such detail. Numerous other variations, changes,and substitutions will occur to those skilled in the art withoutdeparting from the scope of the invention. For instance, the medicaleffector system and components thereof of the invention have applicationin robotic assisted surgery taking into account the obviousmodifications of such systems and components to be compatible with sucha robotic system. It will be understood that the foregoing descriptionis provided by way of example, and that other modifications may occur tothose skilled in the art without departing from the scope and spirit ofthe appended Claims.

1. A drug-delivery cassette assembly comprising: a) a luer; b) tubing having a drug-receiving end which is fluidly-connectable to a drug vial containing a drug and having a drug-delivery end which is fluidly-connected to the luer; and c) a drug-delivery-cassette main board having a luer-site base portion, wherein the luer is attachable to and detachable from the luer-site base portion, and wherein the luer-site base portion has a deflectable luer-site sensor beam which is disposed to be deflected by the luer when the luer is attached to the luer-site base portion and to be undeflected when the luer is detached from the luer-site base portion.
 2. The drug-delivery cassette assembly of claim 1, wherein the cassette main board is attachable to and detachable from a procedure room unit having a luer-in-place optical sensor disposed to sense only one of the deflected luer-site sensor beam and the undeflected luer-site sensor beam.
 3. The drug-delivery cassette assembly of claim 2, wherein the procedure room unit controls flow of the drug in the tubing to air purge the tubing and to deliver the drug through the tubing to a patient based at least in part on the luer-in-place optical sensor sensing or not sensing the luer-site sensor beam.
 4. A drug-delivery cassette assembly comprising: a) a luer; b) a drug-delivery-cassette spike including a drug-vial-seal-perforating spike tip; c) tubing having a drug-receiving end which is fluidly-connectable to and fluidly-disconnectable from the spike and having a drug-delivery end which is fluidly-connected to the luer; and d) a drug-delivery-cassette main board, wherein the spike is attachable to and detachable from the cassette main board.
 5. A drug-delivery cassette assembly comprising: a) a luer; b) tubing having a drug-receiving end which is fluidly-connectable to a drug vial containing a drug and having a drug-delivery end which is fluidly-connected to the luer; and c) a drug-delivery-cassette main board having a luer-site base portion, wherein the luer is attachable to and detachable from the luer-site base portion, and wherein the luer-site base portion has a drip chamber disposed to collect any of the drug which exits the luer when the luer is attached to the luer-site base portion.
 6. The drug-delivery cassette assembly of claim 5, also including a drug-absorbent pad disposed in the drip chamber.
 7. A drug-delivery cassette assembly comprising: a) a luer; and b) tubing including a coiled tube and a flexible tube fluidly-connected together, wherein the flexible tube has a drug-receiving end which is fluidly-connectable to a drug vial containing a drug, wherein the coiled tube has a drug-delivery end which is fluidly-connected to the luer, and wherein the coiled tube is extendible by the user.
 8. The drug-delivery cassette assembly of claim 7, wherein the coiled tube includes a plurality of coils and wherein adjacent coils are releasably adhered together.
 9. The drug-delivery cassette assembly of claim 7, wherein the coiled tube has a smaller inside diameter than the flexible tube. 